Monitoring opioids and sedatives to prevent organ dysfunction and mortality after surgery

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.

This study tests if closely watching pain and sedation levels during surgery can help older patients avoid serious complications and live longer after high-risk operations.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1132 (estimated)
• Ages: 75 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne (Academic / other)
• Locations: 18 sites (Amiens and 17 other locations)
• Trial ID: NCT05893030 on ClinicalTrials.gov

What this trial studies

This study evaluates the impact of monitoring sedation and analgesia during high-risk surgeries to reduce intraoperative hypotension, which can lead to increased postoperative complications and mortality. It focuses on patients over 75 years old with specific postoperative risk factors, assessing the combined optimization of hypnotic and opioid agents. The study aims to demonstrate the benefits of this monitoring approach on postoperative organ dysfunction and mortality, building on previous findings that suggest its effectiveness in major abdominal surgeries.

Who should consider this trial

Good fit: Ideal candidates are patients over 75 years old with at least one postoperative risk factor undergoing high-risk surgery.

Not a fit: Patients who are younger than 75 or do not have any of the specified postoperative risk factors may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of organ dysfunction and mortality in high-risk surgical patients.

How similar studies have performed: While previous studies have shown benefits of monitoring sedation and analgesia in major abdominal surgeries, this specific approach has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Amiens and 17 other locations

• Chu D'Amiens Picardie — Amiens, France (Recruiting)
• Clinique Victor Pauchet — Amiens, France (Recruiting)
• Chru de Besancon — Besançon, France (Not_yet_recruiting)
• Polyclinique Bordeaux Nord Aquitaine — Bordeaux, France (Recruiting)
• Chu Clermont-Ferrand — Clermont-Ferrand, France (Not_yet_recruiting)
• Chu de Grenoble — Grenoble, France (Not_yet_recruiting)
• Chu de Lille — Lille, France (Recruiting)
• APHM - Centre Hôpital Marseille Nord — Marseille, France (Not_yet_recruiting)
• Chu de Nantes — Nantes, France (Not_yet_recruiting)
• Chu de Nimes — Nîmes, France (Recruiting)
• Hopital Bichat Claude Bernard — Paris, France (Recruiting)
• Chu Lyon Sud — Pierre-Bénite, France (Recruiting)
• Chu de Poitiers — Poitiers, France (Recruiting)
• Hôpital Saint Charles — Saint-Dié, France (Not_yet_recruiting)
• Chu St-Etienne — Saint-Etienne, France (Recruiting)
• Chu de Toulouse — Toulouse, France (Recruiting)
• Institut Gustave Roussy — Villejuif, France (Not_yet_recruiting)
• Médipole Lyon Villeurbanne — Villeurbanne, France (Recruiting)

Study contacts

• Principal investigator: David CHARIER, MD, PhD — Chu de Saint-Etienne
• Study coordinator: David CHARIER, MD, PhD

Conditions Sedation and Analgesia Monitoring