Actively Recruiting
Prevention of Organ Dysfunction and Mortality by Monitoring the Administration of Opioids and Hypnotics in Patients at High Postoperative Risk
Led by Centre Hospitalier Universitaire de Saint Etienne · Updated on 2026-02-17
1132
Participants Needed
18
Research Sites
224 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier Universitaire de Saint Etienne
Lead Sponsor
D
Direction Générale de l'Offre de Soins
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prevention of Organ Dysfunction and Mortality by Monitoring the Administration of Opioids and Hypnotics in Patients at High Postoperative Risk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be affiliated with the French Social Security system
- Must provide informed signed consent to participate
- Planned postoperative hospital stay longer than 48 hours
- Age 75 years or older with at least one postoperative risk factor such as ischemic coronary disease, prior or compensated heart failure, stroke, significant arrhythmias, peripheral vascular disease, chronic obstructive pulmonary disease, chronic respiratory failure, kidney insufficiency (creatinine > 175 µmol/L), insulin-treated diabetes, active cancer, chronic alcohol abuse, or dementia
- Scheduled for elective or emergency high-risk surgery under general anesthesia using both hypnotic and opioid drugs with intubation or supraglottic airway device
You will not qualify if you...
- 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 dose > 0.25 mg/kg
- Use of lidocaine or dexmedetomidine continuous infusion
- Refusal to participate in the study
- Under guardianship, conservatorship, or unable to understand the study
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Trial Site Locations
Total: 18 locations
1
Chu D'Amiens Picardie
Amiens, France, 80054
Actively Recruiting
2
Clinique Victor Pauchet
Amiens, France, 80090
Actively Recruiting
3
Chru de Besancon
Besançon, France, 25030
Not Yet Recruiting
4
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France, 33300
Actively Recruiting
5
Chu Clermont-Ferrand
Clermont-Ferrand, France, 63000
Not Yet Recruiting
6
Chu de Grenoble
Grenoble, France, 38700
Not Yet Recruiting
7
Chu de Lille
Lille, France, 59037
Actively Recruiting
8
APHM - Centre Hôpital Marseille Nord
Marseille, France, 13015
Not Yet Recruiting
9
Chu de Nantes
Nantes, France, 44093
Not Yet Recruiting
10
Chu de Nimes
Nîmes, France, 30000
Actively Recruiting
11
Hopital Bichat Claude Bernard
Paris, France, 75018
Actively Recruiting
12
Chu Lyon Sud
Pierre-Bénite, France, 69495
Actively Recruiting
13
Chu de Poitiers
Poitiers, France, 86000
Actively Recruiting
14
Hôpital Saint Charles
Saint-Dié, France, 88100
Not Yet Recruiting
15
Chu St-Etienne
Saint-Etienne, France, 42100
Actively Recruiting
16
Chu de Toulouse
Toulouse, France, 31059
Actively Recruiting
17
Institut Gustave Roussy
Villejuif, France, 94800
Not Yet Recruiting
18
Médipole Lyon Villeurbanne
Villeurbanne, France, 69100
Actively Recruiting
Research Team
D
David CHARIER, MD, PhD
CONTACT
M
Marlène BONNEFOI, CRA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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