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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Chu D'Amiens Picardie
  Amiens, France Recruiting
• Clinique Victor Pauchet
  Amiens, France Recruiting
• Polyclinique Bordeaux Nord Aquitaine
  Bordeaux, France Recruiting
• Chu de Lille
  Lille, France Recruiting
• Chu de Nimes
  Nîmes, France Recruiting
• Hopital Bichat Claude Bernard
  Paris, France Recruiting

Study contacts

• Principal investigator: David CHARIER, MD, PhD — Chu de Saint-Etienne
• Study coordinator: David CHARIER, MD, PhD
• Email: david.charier@chu-st-etienne.fr
• Phone: +33.4.77.82.85.65

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.