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NCT Number: NCT04894864

Opioid Free Anesthesia-Analgesia Strategy and Surgical Stress in Elective Open Abdominal Aortic Aneurysm Repair

Open Abdominal Aortic Aneurysm (AAA) repair is a high-risk surgical procedure accompanied by intense endocrine and metabolic responses to surgical stress, with subsequent activation of the inflammatory cascade, cytokine and acute-phase protein release, and bone marrow activation. There is a proven correlation of surgical stress, which patients undergoing open AAA repair are subjected to, with patient outcome, morbidity/mortality, intensive care unit stay and overall length of stay. Modern general anesthetic techniques have been revised and rely on perioperative multimodal anesthetic and analgesic strategies for improved overall patient outcome. Based on this context of a multimodal anesthetic technique and having taken into consideration the international "opioid-crisis" epidemic, an Opioid Free Anesthesia-Analgesia (OFA-A) strategy started to emerge. It is based on the administration of a variety of anesthetic/analgesic agents with different mechanisms of action, including immunomodulating and anti-inflammatory effects.

Our basic hypothesis is that the implementation of a perioperative multimodal OFA-A strategy, involving the administration of pregabalin, ketamine, dexmedetomidine, lidocaine, dexamethasone, dexketoprofen, paracetamol and magnesium sulphate, will lead to attenuation of surgical stress response compared to a conventional Opioid-Based Anesthesia-Analgesia (OBA-A) strategy. Furthermore, the anticipated attenuation of the inflammatory response, is pressumed to be associated with equal or improved analgesia, compared to a perioperative OBA-A technique.

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Key information

Conditions

Elective Surgical Procedures Abdominal Aortic Aneurysm Without Rupture Anesthesia Immunomodulators Interleukin 6 Neurologic Manifestations Opioid Use Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms Vascular Surgical Procedure

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Crete

Heraklion, Crete, 71110, Greece

Location status: Recruiting

Location contact

George Papastratigakis, MD

CONTACT

[email protected]

00306979056672

About this study

Open abdominal aortic aneurysm (AAA) repair surgery is a high-risk operation, often performed on high-risk patients. Despite advancements made in diagnosis, management, surgical techniques and treatment of these patients, morbidity and mortality remain high. Mortality after open AAA repair remains higher than the average mortality of the matched population for age and sex. Debate is ongoing as to whether open AAA repair or endovascular aneurysm repair (EVAR) is better in terms of overall long-term survival rate.

Regarding open AAA repair, the very nature of the surgery itself, with surgical trauma, aortic cross clamping and its resulting ischemia-reperfusion injury, and cellular interactions of blood with the biomaterial surface of the graft, causes intense and varied metabolic, endocrine and immunological responses. These surgical stress-related responses are evident as marked increases in inflammatory cytokines such as TNF-a, IL-1a, IL-6, IL-8, IL-10, stimulation of the sympathetic system, and stimulation of the hypothalamic-pituitary-adrenal axis, caused by release of CRH and AVP. High levels of IL-6, peaking at 4-48h after clamp removal, have been associated with serious postoperative complications and its levels reflect the intensity of surgical trauma following AAA repair. Other inflammation markers such as CRP and leukocytes have also been shown to increase postoperatively.

While the surgical technique has been extensively studied as to the role it plays on the control of the surgical stress response, patient outcome, morbidity and overall mortality, fewer studies have been conducted to study the effect of the anesthetic management on these factors. While most of them have been focusing on the comparison of general anesthetic vs regional techniques, only few compare different general anesthetic techniques on patient outcome.

Modern general anesthetic techniques have been revised and rely on a multimodal anesthetic and analgesic perioperative regimen for improved patient outcome. A multimodal regimen requires the administration of at least 2 factors with different mechanisms of action. At least one factor causes inhibition of central sensitization and at least another one inhibits the peripheral sensitization of the nervous system, as a response to painful surgical stimuli, mitigating adverse neuroplasticity. One such example, is an Opioid-Free Anesthetic-Analgesic (OFA-A) strategy, which implements a variety of pharmacological agents, including some with demonstrated immunomodulating and anti-inflammatory effects. Apart from sparing any opioid-related adverse effects, an OFA-A multimodal strategy targets optimal analgesia with a multitude of factors in the lowest possible dose, aiming for additive or synergistic effects. An additional advantage of using an OFA-A technique is the prevention of opioid-induced hyperalgesia.

Our hypothesis is that implementation of a multimodal OFA-A strategy, leads to a decreased sympathetic and inflammatory response, compared to conventional opioid-based anesthetic techniques. A decreased inflammatory and stress response as expressed by reduced levels of IL-6, IL-8, IL-10, TNF-a, CRP, cortisol, arginine vasopressin (AVP), white blood cells count and hemodynamic stability is expected to decrease peripheral and central sensitization, contributing to better postoperative analgesia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient Consent
  • Age between 40 and 85 years old
  • Patients undergoing Elective Open Abdominal Aortic Infrarenal Aneurysm Repair

Exclusion criteria

  • Immunocompromised patients
  • Patients with active infection
  • Reoperation on the aorta
  • Inflammatory bowel Disease
  • Malignancy
  • Chronic Inflammatory conditions (e.g. Rheymatoid arthritis, Psoriatic arthritis)
  • Chronic corticosteroid or immunosuppressive drug use
  • Intraoperative transfusion with >2 units of packed Red Blood Cells

Treatment and study plan

Opioid-Based Anesthesia-Analgesia Strategy

Drug

A perioperative Opioid-Based multimodal Anesthesia-Analgesia strategy will be implemented as described in the Opioid-Based arm of the study.

Other names: Opioid-Based Anesthesia, OBA-A

Opioid-free Anesthesia-Analgesia Strategy

Drug

A perioperative Opioid-Free multimodal Anesthesia-Analgesia strategy will be implemented as described in the Opioid-Free arm of the study.

Other names: Opioid-Free Anesthesia, OFA-A

Primary outcomes

  1. Surgical Stress Response - IL-6 - Preoperatively

    Time frame: 1) Preoperatively (as a baseline)

    Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups.

  2. Surgical Stress Response - IL-6 - 15 minutes after aortic cross-clamp

    Time frame: 2) 15 minutes after aortic cross-clamping

    Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups.

  3. Surgical Stress Response - IL-6 - 60 minutes after aortic cross-clamp

    Time frame: 3) 60 minutes after aortic cross-clamp release

    Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups.

  4. Surgical Stress Response - IL-6 - 24 hours after aortic cross-clamp release

    Time frame: 4) 24 hours after aortic cross-clamp release

    Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups.

  5. Surgical Stress Response - IL-8 - Preoperatively

    Time frame: 1) Preoperatively (as a baseline)

    Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups.

  6. Surgical Stress Response - IL-8 - 15 minutes after aortic cross-clamp

    Time frame: 2) 15 minutes after aortic cross-clamping

    Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups.

  7. Surgical Stress Response - IL-8 - 60 minutes after aortic cross-clamp

    Time frame: 3) 60 minutes after aortic cross-clamp release

    Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups.

  8. Surgical Stress Response - IL-8 - 24 hours after aortic cross-clamp release

    Time frame: 4) 24 hours after aortic cross-clamp release

    Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups.

  9. Surgical Stress Response - IL-10 - Preoperatively

    Time frame: 1) Preoperatively (as a baseline)

    Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups.

  10. Surgical Stress Response - IL-10 - 15 minutes after aortic cross-clamp

    Time frame: 2) 15 minutes after aortic cross-clamping

    Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups.

  11. Surgical Stress Response - IL-10 - 60 minutes after aortic cross-clamp

    Time frame: 3) 60 minutes after aortic cross-clamp release

    Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups.

  12. Surgical Stress Response - IL-10 - 24 hours after aortic cross-clamp release

    Time frame: 4) 24 hours after aortic cross-clamp release

    Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups.

  13. Surgical Stress Response - Copeptin - Preoperatively

    Time frame: 1) Preoperatively (as a baseline)

    Inflammatory response and stress response as quantified by Copeptin serum levels. Blood sample collection will take place in both study groups.

  14. Surgical Stress Response - Copeptin - 15 minutes after aortic cross-clamp

    Time frame: 2) 15 minutes after aortic cross-clamping

    Inflammatory response and stress response as quantified by Copeptin serum levels. Blood sample collection will take place in both study groups.

  15. Surgical Stress Response - Copeptin - 60 minutes after aortic cross-clamp

    Time frame: 3) 60 minutes after aortic cross-clamp release

    Inflammatory response and stress response as quantified by Copeptin serum levels. Blood sample collection will take place in both study groups.

  16. Surgical Stress Response - Copeptin - 24 hours after aortic cross-clamp release

    Time frame: 4) 24 hours after aortic cross-clamp release

    Inflammatory response and stress response as quantified by AVP serum levels. Blood sample collection will take place in both study groups.

  17. Surgical Stress Response - TNF-a - Preoperatively

    Time frame: 1) Preoperatively (as a baseline)

    Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups.

  18. Surgical Stress Response - TNF-a - 15 minutes after aortic cross-clamp

    Time frame: 2) 15 minutes after aortic cross-clamping

    Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups.

  19. Surgical Stress Response - TNF-a - 60 minutes after aortic cross-clamp

    Time frame: 3) 60 minutes after aortic cross-clamp release

    Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups.

  20. Surgical Stress Response - TNF-a - 24 hours after aortic cross-clamp release

    Time frame: 4) 24 hours after aortic cross-clamp release

    Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups.

  21. Surgical Stress Response - Cortisol - Preoperatively

    Time frame: 1) Preoperatively (as a baseline)

    Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups.

  22. Surgical Stress Response - Cortisol - 15 minutes after aortic cross-clamp

    Time frame: 2) 15 minutes after aortic cross-clamping

    Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups.

  23. Surgical Stress Response - Cortisol - 60 minutes after aortic cross-clamp

    Time frame: 3) 60 minutes after aortic cross-clamp release

    Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups.

  24. Surgical Stress Response - Cortisol - 24 hours after aortic cross-clamp release

    Time frame: 4) 24 hours after aortic cross-clamp release

    Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups.

  25. Surgical Stress Response - CRP - Preoperatively

    Time frame: 1) Preoperatively (as a baseline)

    Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups.

  26. Surgical Stress Response - CRP - 15 minutes after aortic cross-clamp

    Time frame: 2) 15 minutes after aortic cross-clamping

    Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups.

  27. Surgical Stress Response - CRP - 60 minutes after aortic cross-clamp

    Time frame: 3) 60 minutes after aortic cross-clamp release

    Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups.

  28. Surgical Stress Response - CRP - 24 hours after aortic cross-clamp release

    Time frame: 4) 24 hours after aortic cross-clamp release

    Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups.

  29. Surgical Stress Response - WBC - Preoperatively

    Time frame: 1) Preoperatively (as a baseline)

    Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups.

  30. Surgical Stress Response - WBC - 15 minutes after aortic cross-clamp

    Time frame: 2) 15 minutes after aortic cross-clamping

    Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups.

  31. Surgical Stress Response - WBC - 60 minutes after aortic cross-clamp

    Time frame: 3) 60 minutes after aortic cross-clamp release

    Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups.

  32. Surgical Stress Response - WBC - 24 hours after aortic cross-clamp release

    Time frame: 4) 24 hours after aortic cross-clamp release

    Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups.

  33. Haemodynamic Stability - Tachycardia

    Time frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours

    Intraoperative Tachycardia (defined as PR≥ 100 bpm), with episodes lasting ≥1 minute. Data will be reported in as a percentage of the total surgical time in which the participant exhibited tachycardia.

  34. Haemodynamic Stability - Bradycardia

    Time frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours

    Intraoperative Bradycardia (defined as PR≤ 40 bpm), with episodes lasting ≥1 minute. Data will be reported in as a percentage of the total surgical time in which the participant exhibited bradycardia.

  35. Haemodynamic Stability - Hypotension SBP

    Time frame: Baseline: 5 minutes prior to anaesthesia induction. Intraoperative Hypotension: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours

    Intraoperative Hypotension (defined as SBP≤90mmHg or ≤80% of preoperative Baseline), with episodes lasting ≥1 minute. All patients will have a 5 minute preoperative SBP baseline, with measurements every 20 seconds. Intraoperative data will be compared to the mean preoperative 5 minute SPB baseline. Data will be reported in as a percentage of the total surgical time in which the participant exhibited hypotension, based on the SBP values.

  36. Haemodynamic Stability - Hypotension MBP

    Time frame: Baseline: 5 minutes prior to anaesthesia induction. Intraoperative Hypotension: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours

    Intraoperative Hypotension (defined as MBP≤65mmHg or ≤80% of preoperative Baseline), with episodes lasting ≥1 minute. All patients will have a 5 minute preoperative MBP baseline, with measurements every 20 seconds. Intraoperative data will be compared to the mean preoperative 5 minute MPB baseline. Data will be reported in as a percentage of the total surgical time in which the participant exhibited hypotension, based on the MBP values.

  37. Haemodynamic Stability - Hypertension

    Time frame: Baseline: 5 minutes prior to anaesthesia induction. Intraoperative Hypotension: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours

    Intraoperative Hypertension (defined as SBP ≥120% of preoperative Baseline), with episodes lasting ≥1 minute. All patients will have a 5 minute preoperative SBP baseline, with measurements every 20 seconds. Intraoperative data will be compared to the mean preoperative 5 minute SPB baseline. Data will be reported in as a percentage of the total surgical time in which the participant exhibited hypertension, based on the SBP values.

  38. Haemodynamic Stability - Fluid requirements - Crystalloids - Intraoperatively

    Time frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Crystaloid Fluid Requirements averaged over the total surgical time. Data will be reported in ml/kg*h.

  39. Haemodynamic Stability - Fluid requirements - Crystalloids - 24 hours postoperatively

    Time frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Crystaloid Fluid Requirements. Data will be reported in ml/kg*h.

  40. Haemodynamic Stability - Fluid requirements - Colloids - Intraoperatively

    Time frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Colloid Fluid Requirements averaged over the total surgical time. Data will be reported in ml/kg*h.

  41. Haemodynamic Stability - Fluid requirements - Colloids - 24 hours postoperatively

    Time frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Colloid Fluid Requirements. Data will be reported in ml/kg*h.

  42. Haemodynamic Stability - Fluid requirements - Concentrated RBCs - Intraoperatively

    Time frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Concentrated RBC unit Requirements. Data will be reported in ml.

  43. Haemodynamic Stability - Fluid requirements - Concentrated RBCs - 24 hours postoperatively

    Time frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Concentrated RBC unit Requirements. Data will be reported in ml.

  44. Haemodynamic Stability - Fluid requirements - Plasma - Intraoperatively

    Time frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Plasma unit Requirements. Data will be reported in ml.

  45. Haemodynamic Stability - Fluid requirements - Plasma - 24 hours postoperatively

    Time frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Plasma unit Requirements. Data will be reported in ml.

  46. Haemodynamic Stability - Fluid requirements - Platelets - Intraoperatively

    Time frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Platelet unit Requirements. Data will be reported in ml.

  47. Haemodynamic Stability - Fluid requirements - Platelets - 24 hours postoperatively

    Time frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Platelet unit Requirements. Data will be reported in ml.

  48. Haemodynamic Stability - Blood Loss - Intraoperatively

    Time frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Blood Loss. Data will be reported in ml.

  49. Haemodynamic Stability - Blood Loss - 24 hours postoperatively

    Time frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Blood Loss. Data will be reported in ml.

  50. Haemodynamic Stability - Fluid Balance - Intraoperatively

    Time frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Fluid Balance averaged over the total surgical time. Data will be reported in ml/kg/h

  51. Haemodynamic Stability - Fluid Balance - 24 hours postoperatively

    Time frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Fluid Balance. Data will be reported in ml.

  52. Haemodynamic Stability - Vasoactive Requirements - Adrenaline - Intraoperatively

    Time frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Adrenaline requirements. Data will be reported in mg.

  53. Haemodynamic Stability - Vasoactive Requirements - Adrenaline - 24 hours postoperatively

    Time frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Adrenaline requirements. Data will be reported in mg.

  54. Haemodynamic Stability - Vasoactive Requirements - Noradrenaline - Intraoperatively

    Time frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Noradrenaline requirements. Data will be reported as an averaged intraoperative rate in mcg/kg*min.

  55. Haemodynamic Stability - Vasoactive Requirements - Noradrenaline - 24 hours postoperatively

    Time frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Noradrenaline requirements. Data will be reported as an averaged rate in mcg/kg*min.

  56. Haemodynamic Stability - Vasoactive Requirements - Ephedrine - Intraoperatively

    Time frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Ephedrine requirements. Data will be reported in mg.

  57. Haemodynamic Stability - Vasoactive Requirements - Ephedrine - 24 hours postoperatively

    Time frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Ephedrine requirements. Data will be reported in mg.

  58. Haemodynamic Stability - Vasoactive Requirements - Phenylephrine - Intraoperatively

    Time frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Phenylephrine requirements. Data will be reported as an averaged intraoperative rate in mcg/kg*min.

  59. Haemodynamic Stability - Vasoactive Requirements - Phenylephrine - 24 hours postoperatively

    Time frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Phenylephrine requirements.Data will be reported as an averaged rate in mcg/kg*min.

  60. Haemodynamic Stability - Vasoactive Requirements - Dobutamine - Intraoperatively

    Time frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Dobutamine requirements. Data will be reported as an averaged intraoperative rate in mcg/kg*min.

  61. Haemodynamic Stability - Vasoactive Requirements - Dobutamine - 24 hours postoperatively

    Time frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Dobutamine requirements. Data will be reported as an averaged rate in mcg/kg*min.

  62. Haemodynamic Stability - Vasoactive Requirements - Dopamine - Intraoperatively

    Time frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Dopamine requirements. Data will be reported as an averaged intraoperative rate in mcg/kg*min.

  63. Haemodynamic Stability - Vasoactive Requirements - Dopamine - 24 hours postoperatively

    Time frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Dopamine requirements. Data will be reported as an averaged rate in mcg/kg*min.

  64. Haemodynamic Stability - Vasoactive Requirements - Nitroglycerine - Intraoperatively

    Time frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Nitroglycerine requirements. Data will be reported as an averaged intraoperative rate in mcg/kg*min.

  65. Haemodynamic Stability - Vasoactive Requirements - Nitroglycerine - 24 hours postoperatively

    Time frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Nitroglycerine requirements. Data will be reported as an averaged rate in mcg/kg*min.

Secondary outcomes

  1. Postoperative pain - Numerical Rating Scale (NRS) - Immediately Postoperatively

    Time frame: 1) Immediately postoperatively (if awakened prior to ICU admission)

    Evaluation of patients' pain using scales: Numerical Rating Scale (NRS). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

  2. Postoperative pain - Numerical Rating Scale (NRS) - First postoperative day

    Time frame: 2) First postoperative day

    Evaluation of patients' pain using scales: Numerical Rating Scale (NRS). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

  3. Postoperative pain - Numerical Rating Scale (NRS) - Second postoperative day

    Time frame: 3) Second postoperative day

    Evaluation of patients' pain using scales: Numerical Rating Scale (NRS). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

  4. Postoperative pain - Numerical Rating Scale (NRS) - Third postoperative day

    Time frame: 4) Third postoperative day

    Evaluation of patients' pain using scales: Numerical Rating Scale (NRS). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

  5. Postoperative pain - Critical Care Pain Observation Tool (CPOT) - Immediately Postoperatively

    Time frame: 1) Immediately postoperatively (if awakened prior to ICU admission)

    Evaluation of patients' pain using scales: Critical Care Pain Observation Tool (CPOT). The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients or vocalization for extubated patients. Patient's behavior in each domain is scored between 0 and 2. The possible total score ranges from 0 (no pain) to 8 (maximum pain).

  6. Postoperative pain - Critical Care Pain Observation Tool (CPOT) - First postoperative day

    Time frame: 2) First postoperative day

    Evaluation of patients' pain using scales: Critical Care Pain Observation Tool (CPOT). The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients or vocalization for extubated patients. Patient's behavior in each domain is scored between 0 and 2. The possible total score ranges from 0 (no pain) to 8 (maximum pain).

  7. Postoperative pain - Critical Care Pain Observation Tool (CPOT) - Second postoperative day

    Time frame: 3) Second postoperative day

    Evaluation of patients' pain using scales: Critical Care Pain Observation Tool (CPOT). The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients or vocalization for extubated patients. Patient's behavior in each domain is scored between 0 and 2. The possible total score ranges from 0 (no pain) to 8 (maximum pain).

  8. Postoperative pain - Critical Care Pain Observation Tool (CPOT) - Third postoperative day

    Time frame: 4) Third postoperative day

    Evaluation of patients' pain using scales: Critical Care Pain Observation Tool (CPOT). The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients or vocalization for extubated patients. Patient's behavior in each domain is scored between 0 and 2. The possible total score ranges from 0 (no pain) to 8 (maximum pain).

  9. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Intolerable - First postoperative day

    Time frame: 1) First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    • Intolerable
    • Tolerable with discomfort
    • Comfortably manageable
    • Negligible Pain

    The percentage of patients that report pain that is "Intolerable" will be reported

  10. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Intolerable - Second postoperative day

    Time frame: 2) Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    • Intolerable
    • Tolerable with discomfort
    • Comfortably manageable
    • Negligible Pain

    The percentage of patients that report pain that is "Intolerable" will be reported

  11. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Intolerable - Third postoperative day

    Time frame: 3) Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    • Intolerable
    • Tolerable with discomfort
    • Comfortably manageable
    • Negligible Pain

    The percentage of patients that report pain that is "Intolerable" will be reported

  12. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Tolerable with discomfort - First postoperative day

    Time frame: 1) First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    • Intolerable
    • Tolerable with discomfort
    • Comfortably manageable
    • Negligible Pain

    The percentage of patients that report pain that is "Tolerable with discomfort" will be reported

  13. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Tolerable with discomfort - Second postoperative day

    Time frame: 2) Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    • Intolerable
    • Tolerable with discomfort
    • Comfortably manageable
    • Negligible Pain

    The percentage of patients that report pain that is "Tolerable with discomfort" will be reported

  14. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Tolerable with discomfort - Third postoperative day

    Time frame: 3) Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    • Intolerable
    • Tolerable with discomfort
    • Comfortably manageable
    • Negligible Pain

    The percentage of patients that report pain that is "Tolerable with discomfort" will be reported

  15. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Comfortably manageable - First postoperative day

    Time frame: 1) First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    • Intolerable
    • Tolerable with discomfort
    • Comfortably manageable
    • Negligible Pain

    The percentage of patients that report pain that is "Comfortably manageable" will be reported

  16. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Comfortably manageable - Second postoperative day

    Time frame: 2) Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    • Intolerable
    • Tolerable with discomfort
    • Comfortably manageable
    • Negligible Pain

    The percentage of patients that report pain that is "Comfortably manageable" will be reported

  17. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Comfortably manageable - Third postoperative day

    Time frame: 3) Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    • Intolerable
    • Tolerable with discomfort
    • Comfortably manageable
    • Negligible Pain

    The percentage of patients that report pain that is "Comfortably manageable" will be reported

  18. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Negligible Pain - First postoperative day

    Time frame: 1) First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    • Intolerable
    • Tolerable with discomfort
    • Comfortably manageable
    • Negligible Pain

    The percentage of patients that report pain that is "Negligible Pain" will be reported

  19. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Negligible Pain - Second postoperative day

    Time frame: 2) Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    • Intolerable
    • Tolerable with discomfort
    • Comfortably manageable
    • Negligible Pain

    The percentage of patients that report pain that is "Negligible Pain" will be reported

  20. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Negligible Pain - Third postoperative day

    Time frame: 3) Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    • Intolerable
    • Tolerable with discomfort
    • Comfortably manageable
    • Negligible Pain

    The percentage of patients that report pain that is "Negligible Pain" will be reported

  21. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting Worse - First postoperative day

    Time frame: 1) First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:

    • Getting worse
    • About the same
    • Getting better

    The percentage of patients that report pain that is "Getting worse" will be reported

  22. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting Worse - Second postoperative day

    Time frame: 2) Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:

    • Getting worse
    • About the same
    • Getting better

    The percentage of patients that report pain that is "Getting worse" will be reported

  23. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting Worse - Third postoperative day

    Time frame: 3) Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:

    • Getting worse
    • About the same
    • Getting better

    The percentage of patients that report pain that is "Getting worse" will be reported

  24. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - About the same - First postoperative day

    Time frame: 1) First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:

    • Getting worse
    • About the same
    • Getting better

    The percentage of patients that report pain that is "About the same" will be reported

  25. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - About the same - Second postoperative day

    Time frame: 2) Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:

    • Getting worse
    • About the same
    • Getting better

    The percentage of patients that report pain that is "About the same" will be reported

  26. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - About the same - Third postoperative day

    Time frame: 3) Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:

    • Getting worse
    • About the same
    • Getting better

    The percentage of patients that report pain that is "About the same" will be reported

  27. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting better

    Time frame: 1) First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:

    • Getting worse
    • About the same
    • Getting better

    The percentage of patients that report pain that is "Getting better" will be reported

  28. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting better - Second postoperative day

    Time frame: 2) Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:

    • Getting worse
    • About the same
    • Getting better

    The percentage of patients that report pain that is "Getting better" will be reported

  29. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting better - Third postoperative day

    Time frame: 3) Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:

    • Getting worse
    • About the same
    • Getting better

    The percentage of patients that report pain that is "Getting better" will be reported

  30. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Inadequate pain control - First postoperative day

    Time frame: 1) First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:

    • Inadequate pain control
    • Effective, just about right
    • Would like to reduce medication

    The percentage of patients that report "Inadequate pain control" will be reported

  31. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Inadequate pain control - Second postoperative day

    Time frame: 2) Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:

    • Inadequate pain control
    • Effective, just about right
    • Would like to reduce medication

    The percentage of patients that report "Inadequate pain control" will be reported

  32. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Inadequate pain control - Third postoperative day

    Time frame: 3) Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:

    • Inadequate pain control
    • Effective, just about right
    • Would like to reduce medication

    The percentage of patients that report "Inadequate pain control" will be reported

  33. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Effective, just about right - First postoperative day

    Time frame: 1) First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:

    • Inadequate pain control
    • Effective, just about right
    • Would like to reduce medication

    The percentage of patients that report pain control that is "Effective, just about right" will be reported

  34. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Effective, just about right - Second postoperative day

    Time frame: 2) Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:

    • Inadequate pain control
    • Effective, just about right
    • Would like to reduce medication

    The percentage of patients that report pain control that is "Effective, just about right" will be reported

  35. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Effective, just about right - Third postoperative day

    Time frame: 3) Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:

    • Inadequate pain control
    • Effective, just about right
    • Would like to reduce medication

    The percentage of patients that report pain control that is "Effective, just about right" will be reported

  36. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Would like to reduce medication - First postoperative day

    Time frame: 1) First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:

    • Inadequate pain control
    • Effective, just about right
    • Would like to reduce medication

    The percentage of patients whose pain control is reported as "Would like to reduce medication" will be reported

  37. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Would like to reduce medication - Second postoperative day

    Time frame: 2) Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:

    • Inadequate pain control
    • Effective, just about right
    • Would like to reduce medication

    The percentage of patients whose pain control is reported as "Would like to reduce medication" will be reported

  38. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Would like to reduce medication - Third postoperative day

    Time frame: 3) Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:

    • Inadequate pain control
    • Effective, just about right
    • Would like to reduce medication

    The percentage of patients whose pain control is reported as "Would like to reduce medication" will be reported

  39. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can't do anything because of pain - First postoperative day

    Time frame: 1) First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    • Can't do anything because of pain
    • Pain keeps me from doing most of what I need to do
    • Can do most things, but pain gets in the way of some
    • Can do everything I need to do

    The percentage of patients whose functioning is reported as "Can't do anything because of pain" will be reported

  40. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can't do anything because of pain - Second postoperative day

    Time frame: 2) Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    • Can't do anything because of pain
    • Pain keeps me from doing most of what I need to do
    • Can do most things, but pain gets in the way of some
    • Can do everything I need to do

    The percentage of patients whose functioning is reported as "Can't do anything because of pain" will be reported

  41. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can't do anything because of pain - Third postoperative day

    Time frame: 3) Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    • Can't do anything because of pain
    • Pain keeps me from doing most of what I need to do
    • Can do most things, but pain gets in the way of some
    • Can do everything I need to do

    The percentage of patients whose functioning is reported as "Can't do anything because of pain" will be reported

  42. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Pain keeps me from doing most of what I need to do - First postoperative day

    Time frame: 1) First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    • Can't do anything because of pain
    • Pain keeps me from doing most of what I need to do
    • Can do most things, but pain gets in the way of some
    • Can do everything I need to do

    The percentage of patients whose functioning is reported as "Pain keeps me from doing most of what I need to do" will be reported

  43. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Pain keeps me from doing most of what I need to do - Second postoperative day

    Time frame: 2) Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    • Can't do anything because of pain
    • Pain keeps me from doing most of what I need to do
    • Can do most things, but pain gets in the way of some
    • Can do everything I need to do

    The percentage of patients whose functioning is reported as "Pain keeps me from doing most of what I need to do" will be reported

  44. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Pain keeps me from doing most of what I need to do - Third postoperative day

    Time frame: 3) Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    • Can't do anything because of pain
    • Pain keeps me from doing most of what I need to do
    • Can do most things, but pain gets in the way of some
    • Can do everything I need to do

    The percentage of patients whose functioning is reported as "Pain keeps me from doing most of what I need to do" will be reported

  45. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do most things, but pain gets in the way of some - First postoperative day

    Time frame: 1) First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    • Can't do anything because of pain
    • Pain keeps me from doing most of what I need to do
    • Can do most things, but pain gets in the way of some
    • Can do everything I need to do

    The percentage of patients whose functioning is reported as "Can do most things, but pain gets in the way of some" will be reported

  46. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do most things, but pain gets in the way of some - Second postoperative day

    Time frame: 2) Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    • Can't do anything because of pain
    • Pain keeps me from doing most of what I need to do
    • Can do most things, but pain gets in the way of some
    • Can do everything I need to do

    The percentage of patients whose functioning is reported as "Can do most things, but pain gets in the way of some" will be reported

  47. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do most things, but pain gets in the way of some - Third postoperative day

    Time frame: 3) Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    • Can't do anything because of pain
    • Pain keeps me from doing most of what I need to do
    • Can do most things, but pain gets in the way of some
    • Can do everything I need to do

    The percentage of patients whose functioning is reported as "Can do most things, but pain gets in the way of some" will be reported

  48. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do everything I need to do - First postoperative day

    Time frame: 1) First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    • Can't do anything because of pain
    • Pain keeps me from doing most of what I need to do
    • Can do most things, but pain gets in the way of some
    • Can do everything I need to do

    The percentage of patients whose functioning is reported as "Can do everything I need to do" will be reported

  49. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do everything I need to do - Second postoperative day

    Time frame: 2) Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    • Can't do anything because of pain
    • Pain keeps me from doing most of what I need to do
    • Can do most things, but pain gets in the way of some
    • Can do everything I need to do

    The percentage of patients whose functioning is reported as "Can do everything I need to do" will be reported

  50. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do everything I need to do - Third postoperative day

    Time frame: 3) Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    • Can't do anything because of pain
    • Pain keeps me from doing most of what I need to do
    • Can do most things, but pain gets in the way of some
    • Can do everything I need to do

    The percentage of patients whose functioning is reported as "Can do everything I need to do" will be reported

  51. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with pain most of the night - First postoperative day

    Time frame: 1) First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:

    • Awake with pain most of the night
    • Awake with occasional pain
    • Normal sleep

    The percentage of patients whose sleep is reported as "Awake with pain most of the night" will be reported

  52. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with pain most of the night - Second postoperative day

    Time frame: 2) Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:

    • Awake with pain most of the night
    • Awake with occasional pain
    • Normal sleep

    The percentage of patients whose sleep is reported as "Awake with pain most of the night" will be reported

  53. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with pain most of the night - Third postoperative day

    Time frame: 3) Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:

    • Awake with pain most of the night
    • Awake with occasional pain
    • Normal sleep

    The percentage of patients whose sleep is reported as "Awake with pain most of the night" will be reported

  54. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with occasional pain - First postoperative day

    Time frame: 1) First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:

    • Awake with pain most of the night
    • Awake with occasional pain
    • Normal sleep

    The percentage of patients whose sleep is reported as "Awake with occasional pain" will be reported

  55. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with occasional pain - Second postoperative day

    Time frame: 2) Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:

    • Awake with pain most of the night
    • Awake with occasional pain
    • Normal sleep

    The percentage of patients whose sleep is reported as "Awake with occasional pain" will be reported

  56. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with occasional pain - Third postoperative day

    Time frame: 3) Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:

    • Awake with pain most of the night
    • Awake with occasional pain
    • Normal sleep

    The percentage of patients whose sleep is reported as "Awake with occasional pain" will be reported

  57. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Normal sleep - First postoperative day

    Time frame: 1) First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:

    • Awake with pain most of the night
    • Awake with occasional pain
    • Normal sleep

    The percentage of patients whose sleep is reported as "Normal sleep" will be reported

  58. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Normal sleep - Second postoperative day

    Time frame: 2) Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:

    • Awake with pain most of the night
    • Awake with occasional pain
    • Normal sleep

    The percentage of patients whose sleep is reported as "Normal sleep" will be reported

  59. Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Normal sleep - Third postoperative day

    Time frame: 3) Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:

    • Awake with pain most of the night
    • Awake with occasional pain
    • Normal sleep

    The percentage of patients whose sleep is reported as "Normal sleep" will be reported

  60. Analgesic Requirements - First postoperative day

    Time frame: 1) First postoperative day

    Evaluation of patients' pain by recording the number of times that rescue analgesia (tramadol) was required.

  61. Analgesic Requirements - Second postoperative day

    Time frame: 2) Second postoperative day

    Evaluation of patients' pain by recording the number of times that rescue analgesia (tramadol) was required.

  62. Analgesic Requirements - Third postoperative day

    Time frame: 3) Third postoperative day

    Evaluation of patients' pain by recording the number of times that rescue analgesia (tramadol) was required.

  63. Kidney function - Furosemide requirement - Intraoperatively

    Time frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours

    Kidney function as quantified by furosemide requirement to maintain urine output. Data will be reported in mg.

  64. Kidney function - Furosemide requirement - 24 hours postoperatively

    Time frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively

    Kidney function as quantified by furosemide requirement to maintain urine output. Data will be reported in mg.

  65. Kidney function - MDRD GFR - Preoperatively

    Time frame: 1) Preoperatively (as a baseline)

    Kidney function as assessed by preoperative GFR calculated by the MDRD GFR equation.

  66. Kidney function - MDRD GFR - Immediately postoperatively

    Time frame: 2) At the end of surgery 1h after the end of placement of last suture/surgical clip on patient, upon ICU admission.

    Kidney function as assessed by postoperative GFR calculated by the MDRD GFR equation.

  67. Kidney function - MDRD GFR - 24h Postoperatively

    Time frame: 3) 24h postoperatively

    Kidney function as assessed by postoperative GFR calculated by the MDRD GFR equation.

  68. Kidney function - Urine Output - Intraoperatively

    Time frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours

    Kidney function as quantified by urine output. Data will be reported as an averaged intraoperative rate in ml/kg*h.

  69. Kidney function - Urine Output - 24 hours postoperatively

    Time frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively

    Kidney function as quantified by urine output. Data will be reported as an averaged rate in ml/kg*h.

  70. Length of stay - ICU

    Time frame: From day of surgery until day of ICU stay.

    All patients will spend at least 1 day in the ICU for postoperative monitoring. ICU length of stay will be reported in days.

  71. Length of stay - Hospital Discharge

    Time frame: From day of surgery until hospital discharge

    Hospital length of stay will be reported in days.

Other outcomes

  1. Haemodynamic Stability - Coefficient of Variation PR

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours.

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate - PR. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. The Coefficient of variation of the PR values will be reported for each patient, extracted from the collected data.

  2. Haemodynamic Stability - Average Real Variability PR

    Time frame: Every minute from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours.

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Average Real Variability of the PR. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Values will be averaged every minute and the Average Real Variability will be reported for each patient, extracted from the collected data.

  3. Haemodynamic Stability - Coefficient of Variation SBP

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours.

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure - SBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. The Coefficient of variation of SBP values will be reported for each patient, extracted from the collected data.

  4. Haemodynamic Stability - Average Real Variability SBP

    Time frame: Every minute from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours.

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Average Real Variability of the SBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Values will be averaged every minute and the Average Real Variability will be reported for each patient, extracted from the collected data.

  5. Haemodynamic Stability - Coefficient of Variation DBP

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours.

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure - DBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. The Coefficient of variation of DBP values will be reported for each patient, extracted from the collected data.

  6. Haemodynamic Stability - Average Real Variability DBP

    Time frame: Every minute from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours.

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Average Real Variability of the DBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Values will be averaged every minute and the Average Real Variability will be reported for each patient, extracted from the collected data.

  7. Haemodynamic Stability - Coefficient of Variation MBP

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours.

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure - MBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. The Coefficient of variation of MBP values will be reported for each patient, extracted from the collected data.

  8. Haemodynamic Stability - Average Real Variability MBP

    Time frame: Every minute from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours.

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Average Real Variability of the MBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Values will be averaged every minute and the Average Real Variability will be reported for each patient, extracted from the collected data.

  9. Haemodynamic Stability - Coefficient of Variation PP

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours.

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Pressure. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. The Coefficient of variation of PP values will be reported for each patient, extracted from the collected data.

  10. Haemodynamic Stability - Average Real Variability PP

    Time frame: Every minute from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours.

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Average Real Variability of the PP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Values will be averaged every minute and the Average Real Variability will be reported for each patient, extracted from the collected data.

Study contacts

Contact information is provided by the study sponsor or research team.

George Papastratigakis, MD

CONTACT

[email protected]

00306979056672

Georgios Stefanakis, MD

CONTACT

[email protected]

00306978779726

Sponsors and collaborators

Lead sponsor

University of Crete

Other

Collaborators

  • University Hospital of Crete

Registry information

Official study title

Effect of a Perioperative Opioid Free Anesthesia-Analgesia (OFA-A) Strategy on Surgical Stress Response in Elective Open Abdominal Aortic Aneurysm Repair: A Prospective Randomized Study

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
May 20, 2021
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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