Actively Recruiting

Phase Not Applicable
Age: 75Years +
All Genders
NCT05893030

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

Age: 75Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Screening

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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

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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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