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Completed

NCT Number: NCT06132490

Intra-abdominal Pressure and Insufflator Effects in Robotic Surgery

The main aim of this study is to compare the perioperative effects of different intra-abdominal pressures and different insufflators in patients undergoing robotic surgery at a 30-45 degree trendelenburg position.

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Key information

Conditions

Post Operative Pain Complication,Postoperative Hemodynamic Instability Hypercapnia Intraoperative Complications Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Koç University

Istanbul, 34010, Turkey (Türkiye)

About this study

Adult patients scheduled for robotic genitourinary or colorectal surgery are going to be enrolled in this study. Patients will be randomized in three groups. In group I, conventional insufflators will be used with 12 mmHg intra-abdominal pressure; in group II, valveless insufflators will be used with 12 mmHg intra-abdominal pressure and in group III, valveless insufflators will be used with 8 mmHg intra-abdominal pressure. Intraoperative data regarding airway pressures, lung compliance, hemodynamic parameters, arterial blood gas analysis, times of pressure loss and camera cleaning will be gathered. Each patient will receive a standardized anesthesia and analgesia procedure with a intravenous morphine patient controlled analgesia (PCA). Postoperative pain will be monitored at 1st, 3rd, 6th, 12th and 24th postoperative hours and morphine consumption rates will be recorded. Patient length of stay, time to first flatus, urine output, postoperative complications(graded by Clavien Dindo classification), preoperative and postoperative hemoglobin and creatinine levels will be filed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Elective robotic surgery with intraabdominal insufflation and trendelenburg position (prostatectomy, hemicolectomy etc.)
  • ASA (American Society of Anesthesiologists) Physical Status I-II-III

Exclusion criteria

  • Patients without consent
  • Emergency surgery
  • Bleeding diathesis
  • Pregnancy or lactation
  • Prior history of major abdominal/pelvic surgery
  • Chronic kidney disease
  • Chronic opioid consumption for chronic pain
  • Inability to communicate with the patient due to language barriers or mental status

Treatment and study plan

Valveless Insufflator with 12 mmHg intra-abdominal pressure

Device

In this group valveless insufflators, which are relatively new in clinical practice, will be used under low intra-abdominal pressure throughout the surgery.

Valveless Insufflator with 8 mmHg intra-abdominal pressure

Device

In this group valveless insufflators, which are relatively new in clinical practice, will be used under ultra-low intra-abdominal pressure throughout the surgery.

Primary outcomes

  1. Number of manipulations done by the attending anesthesiologists

    Time frame: Intraoperative

    After the induction of general anesthesia, orotracheal intubation and arterial catheterization; a standard ventilation and anesthesia maintenance strategy will be applied. Every manipulation performed to keep the parameters monitored by the anesthesiologists within physiological limits will be recorded: ventilation frequency setting, remifentail infusion titration, administration of vasoactive agents, etc.

Secondary outcomes

  1. Arterial blood gas lactate levels

    Time frame: Intraoperative

    Arterial blood gas will be sampled at standardized times during the operation and lactate levels will be compared among the groups

  2. Peak airway pressures

    Time frame: Intraoperative

    Peak airway pressures (cmH2O) will be compared among the groups

  3. Mean airway pressures

    Time frame: Intraoperative

    Mean airway pressures (cmH2O) will be compared among the groups

  4. Lung compliance

    Time frame: Intraoperative

    Lung compliance (mL/cmH2O) will be compared among the groups

  5. End tidal carbon dioxide levels

    Time frame: Intraoperative

    End tidal carbon dioxide levels (mmHg) will be compared among the groups

  6. Minute ventilation

    Time frame: Intraoperative

    Minute ventilation (L/minute) will be compared among the groups

  7. Systolic blood pressure

    Time frame: Intraoperative

    Systolic arterial pressures (mmHg) will be compared among the groups.

  8. Diastolic blood pressure

    Time frame: Intraoperative

    Diastolic arterial pressures (mmHg) will be compared among the groups.

  9. Mean blood pressure

    Time frame: Intraoperative

    Mean arterial pressures (mmHg) will be compared among the groups.

  10. Heart rate

    Time frame: Intraoperative

    Heart rate (beat per minute) will be compared among the groups

  11. Acute Postoperative Pain

    Time frame: Postoperative 24 hours

    Acute postoperative pain reported with numeric rating scale (0-10) will be recorded at postoperative 1st, 3rd, 6th, 12th and 24th hours with 0 meaning no pain and 10 meaning worst imaginable pain.

  12. Postoperative morphine consumption

    Time frame: Postoperative 24 hours

    Intravenous morphine consumption (mg) will be recorded at postoperative 1st, 3rd, 6th, 12th and 24th hours

  13. Anesthesia time and operative time

    Time frame: Intraoperative

    Anesthesia and operative times wil be recorded as minutes

  14. Intraoperative bleeding

    Time frame: Intraoperative

    Total bleeding level estimated by the surgical nurse will be recorded as milliliters at the end of the surgery

  15. Urine output

    Time frame: Intraoperative and daily untill discharge

    Kidney function will be monitored by using intraoperative and daily postoperative urine output (mL)

  16. Creatinine levels

    Time frame: Preoperative and postoperative (up to one month)

    Kidney function will be monitored by using daily creatinine levels (mg/dL)

  17. Hemoglobin levels

    Time frame: Intraoperative and daily untill discharge

    Intraoperative and daily postoperative hemoglobin levels will be recorded

  18. Need for blood product transfusion

    Time frame: Intraoperative and daily untill discharge

    Blood product transfusions will be recorded

  19. Number of participants with pulmonary complications

    Time frame: Postoperative, up to one month

    Pulmonary complications like atelectasis, pulmonary oedema, pleural effusion, pneumothorax, pneumonia, ventilatory failure will be recorded for each patient. And number of patients with pulmonary complications will be compared among the groups.

  20. Flatus time

    Time frame: Postoperative one week

    Postoperative time to first flatus will be recorded

  21. Time to oral intake

    Time frame: Postoperative 3 days

    Postoperative time to oral intake will be recorded

  22. Number of participants with subcutaneous emphysema

    Time frame: Postoperative, up to one month

    Subcutaneous emphysema diagnosed with chest radiograph will be recorded

  23. Length of hospital stay

    Time frame: Postoperative, up to one month

    Length of hospital stay will be recorded as hours

  24. The Clavien-Dindo classification of surgical complications

    Time frame: Postoperative, up to one month

    Any postoperative complication will be graded by the Clavien-Dindo classification between I to V with I meaning any deviation from the postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions and V meaning death of a patient.

Sponsors and collaborators

Lead sponsor

Koç University

Other

Registry information

Official study title

Comparison of the Perioperative Effects of Intra-abdominal Pressure Created With Standard and Valveless Insufflators in Robotic Surgery

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 15, 2023
Registry last updated
Mar 15, 2024

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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