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

Last updated: November 14, 2024
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

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

anesthesia guided by sedation and analgesia monitoring

Clinical Study ID

NCT05893030
20PH283
ANSM
  • Ages > 75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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;

  • acute respiratory failure or pneumonia;

  • septic shock;

  • acute stroke;

  • cardiac surgery;

  • open chest surgery;

  • opioid free anesthesia;

  • intraoperative ketamine at a dose > 0.2 mg.kg-1;

  • lidocaine or dexmedetomidine by continuous infusion;

  • refusal to participate in the study;

Study Design

Total Participants: 1132
Treatment Group(s): 2
Primary Treatment: anesthesia performed according only to the clinical judgment of the anesthetist as usual practice
Phase:
Study Start date:
October 12, 2023
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Chu D'Amiens Picardie

    Amiens, 80054
    France

    Site Not Available

  • Chru de Besancon

    Besançon, 25030
    France

    Site Not Available

  • Chu Clermont-Ferrand

    Clermont-Ferrand, 63000
    France

    Site Not Available

  • Chu de Grenoble

    Grenoble, 38700
    France

    Site Not Available

  • Chu de Lille

    Lille, 59037
    France

    Site Not Available

  • APHM - Centre Hôpital Marseille Nord

    Marseille, 13015
    France

    Site Not Available

  • Chu de Nantes

    Nantes, 44093
    France

    Site Not Available

  • Chu de Nimes

    Nîmes, 30000
    France

    Site Not Available

  • Hopital Bichat Claude Bernard

    Paris, 75018
    France

    Site Not Available

  • Chu Lyon Sud

    Pierre-Bénite, 69495
    France

    Site Not Available

  • Chu de Poitiers

    Poitiers, 86000
    France

    Site Not Available

  • Chu St-Etienne

    Saint-Étienne, 42100
    France

    Active - Recruiting

  • Chu de Toulouse

    Toulouse, 31059
    France

    Site Not Available

  • Médipole Lyon Villeurbanne

    Villeurbanne, 69100
    France

    Site Not Available

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