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NCT Number: NCT05893030

Prevention of Organ Dysfunction and Mortality by Monitoring the Administration of Opioids and Hypnotics in Patients at High Postoperative Risk

Intraoperative hypotension is a common situation. It increases postoperative morbidity and mortality, especially in patients at high postoperative risk undergoing high-risk surgery. Intraoperative hypotension is partly related to anesthesia, and mainly to the combined, dose-dependent, synergistic effect of hypnotics and opioids. Monitoring sedation and monitoring analgesia reduce intraoperative consumption of each anesthetic agent. To date, the beneficial effect of combined sedation and analgesia monitoring on the reduction of intraoperative hypotension has only been found in one study, involving major abdominal surgery. Up to now, no study has been designed to demonstrate the benefit of monitoring the two components of anesthesia on postoperative organ dysfunction and mortality.

The study propose to evaluate the relevance of a combined optimization of hypnotic and opioid agents on the most frequently encountered dysfunctions related to intraoperative hypotension.

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Key information

Conditions

Sedation and Analgesia Monitoring

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu D'Amiens Picardie, Amiens, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients affiliated to the French Social Security;
  • informed and signed consent to participating in the study;
  • planned postoperative hospitalization > 48 hours;
  • patients over 75 years of age with at least one of the following postoperative risk factors:
  • ischemic coronary disease;
  • history of compensated or prior heart failure;
  • stroke;
  • significant arrhythmias: fibrillation or auricular flutter with ventricular response > 100/minute, multiform QRS complex) or cardiac conduction abnormalities (trifascicular block, auriculoventricular block of the second or third degree);
  • peripheral vascular disease;
  • chronic obstructive pulmonary disease;
  • chronic respiratory failure;
  • renal insufficiency, defined by a creatinine > 175 µmol.l-1 (2 mg.dl-1);
  • insulin therapy for diabetes;
  • active cancer;
  • chronic alcohol abuse;
  • dementia.
  • elective or emergency high-risk surgery under general anesthesia with a combination of hypnotic and opioid, and intubation or placement of a supraglottic airway control device

Non inclusion criteria:

  • Patients who meet one or more of the preoperative following criteria will not be included:
  • acute heart failure or acute myocardial infarction;
  • complete arrhythmia due to atrial fibrillation;
  • acute respiratory failure or pneumonia;
  • septic shock;
  • acute stroke;
  • cardiac surgery;
  • open chest surgery;
  • opioid free anesthesia;
  • intraoperative ketamine at a dose > 0.25 mg.kg-1; > 0.25 mg/kg or or intravenous electric syringe
  • lidocaine or dexmedetomidine by continuous infusion;
  • refusal to participate in the study;
  • patient under guardianship, conservatorship, or unable to understand the study.

Treatment and study plan

anesthesia guided by sedation and analgesia monitoring

Procedure

Anesthesia guided by sedation and analgesia monitoring The level of sedation will be monitored by

  • Monitoring System BIS™ : Bispectral index (BIS) between 45 and 60 AND Suppression Ratio (SR) at 0;
  • or SedLine® Sedation Monitor : Patient State Index (PSi) between 25 and 50;
  • or Entropy Sensor™: State entropy (SE) between 45 and 60 AND Burst Suppression Ratio (BSR) at 0;

and the level of nociception by :

  • Nociception monitor PMD-200® : Nociception Level (NoL) between 10 and 25.

anesthesia performed according only to the clinical judgment of the anesthetist as usual practice

Procedure

Administration of anesthesia will be performed according to the clinical judgment of the anesthetist as usual practice without sedation and analgesia monitoring

Primary outcomes

  1. death

    Time frame: Day 30

  2. Postoperative acute kidney injury (PO-AKI)

    Time frame: Day 30

    The PO-AKI will be defined as an increase to 1.5 times the reference level, or as more than 0.3 mg.dl-1 (i.e. 26.5 µmol.l-1) between the last preoperative value and the maximal value observed after surgery, or urine volume < 0.5 ml.kg-1.h-1 for 6 hours, according to the recommendations of the Acute Kidney Injury Network

  3. cardiovascular complication

    Time frame: Day 30

    postoperative myocardial infarction, acute heart failure, acute/non pre-existing atrial fibrillation or flutter, cardiac arrest with successful resuscitation, coronary revascularisation

  4. neurological complication

    Time frame: Day 30

    Stroke or transient ischemic attack

  5. Post-operative delirium (POD)

    Time frame: Day 30

    Post-operative delirium (POD) will be evaluated using the 3-minute Diagnostic Confusion Assessment Method (3D-CAM), appropriated and validated for the assessment of delirium in the postoperative period, or the Confusion Assessment Method for Intensive Care Unit (CAM-ICU) for the intubated patients.

Secondary outcomes

  1. doses of hypnotics administered

    Time frame: during surgery

  2. doses opioids administered;

    Time frame: during surgery

  3. number and duration of hypotensive periods

    Time frame: during surgery

    an hypotensive event will be defined as a Mean Arterial Pressure (MAP) ≤ 65 mmHg.

  4. time spent within the desired range of sedation:

    Time frame: during surgery

    Monitoring System BIS™ : Bispectral index (BIS) between 45 and 60 AND Suppression Ratio (SR) at 0 or SedLine® Sedation Monitor : Patient State Index (PSI) between 25 and 50 AND Suppression Ratio (SR) at 0 or Entropy Sensor™: State entropy (SE) between 45 and 60 AND Burst Suppression Ratio (BSR) at 0 The anesthetist will have access to the value of sedation monitoring in the "intervention" group; these data will be recorded but not available to the anesthetist in the "control" group: they will be analyzed at the end of the study to answer this point.

  5. time spent within the desired range of analgesia:

    Time frame: during surgery

    Nociception monitor PMD-200® : Nociception Level (NOL) between 10 and 25. The anesthetist will have access to the value of sedation and analgesia monitoring in the "intervention" group; these data will be recorded but not available to the anesthetist in the "control" group: they will be analyzed at the end of the study to answer this point.

  6. doses of vasopressive amines (ephedrine or norepinephrine) administered;

    Time frame: during surgery

  7. pain ≥ 5 as assessed with the Visual Analogic Scale (VAS)

    Time frame: At 48 Hours after surgery

    VAS 0 to 10 [0 corresponds to no pain - 10 corresponds to maximum pain]

  8. dose of opioid administered;

    Time frame: At 48 Hours after surgery

  9. incidence of awareness and recall during anesthesia (explicit memory).

    Time frame: At 48 Hours after surgery

  10. acute respiratory failure or Acute Respiratory Distress Syndrome (ARDS)

    Time frame: Day 30

  11. duration of stay in Intensive Care Unit (ICU);

    Time frame: Day 30

  12. rate of unexpected ICU admission, or readmission

    Time frame: Day 30

  13. duration of hospital stay;

    Time frame: Day 30

  14. early hospital readmission rate

    Time frame: Day 30

Study contacts

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

David CHARIER, MD, PhD

CONTACT

[email protected]

+33.4.77.82.85.65

Marlène BONNEFOI, CRA

CONTACT

[email protected]

(0)477828822 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Direction Générale de l'Offre de Soins

Registry information

Official study title

Prevention of Organ Dysfunction and Mortality by Monitoring the Administration of Opioids and Hypnotics in Patients at High Postoperative Risk: the Opti-Two Study. A Multi-center Controlled Randomized Study.

Acronym: OPTI-TWO

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jun 7, 2023
Registry last updated
Feb 17, 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.