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

NCT05893030 | Recruiting DMC

• 2 other identifiers: 20PH283ANSM
• Study Type: interventional
• Target: 1,132
• Locations: 1 country
• Sites: 18

Brief 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.

Conditions

Sedation and Analgesia Monitoring

Outcome Measures

Primary Outcomes (5)

• death

  Day 30

• Postoperative acute kidney injury (PO-AKI)

  The PO-AKI will be defined as an increase to 1.5 times the reference level, or as more than 0.3 mg.dl-1 (i.e. 26.5 µmol.l-1) between the last preoperative value and the maximal value observed after surgery, or urine volume \< 0.5 ml.kg-1.h-1 for 6 hours, according to the recommendations of the Acute Kidney Injury Network

  Day 30

• cardiovascular complication

  postoperative myocardial infarction, acute heart failure, acute/non pre-existing atrial fibrillation or flutter, cardiac arrest with successful resuscitation, coronary revascularisation

  Day 30

• neurological complication

  Stroke or transient ischemic attack

  Day 30

• Post-operative delirium (POD)

  Post-operative delirium (POD) will be evaluated using the 3-minute Diagnostic Confusion Assessment Method (3D-CAM), appropriated and validated for the assessment of delirium in the postoperative period, or the Confusion Assessment Method for Intensive Care Unit (CAM-ICU) for the intubated patients.

  Day 30

Secondary Outcomes (14)

• doses of hypnotics administered

  during surgery

• doses opioids administered;

  during surgery

• number and duration of hypotensive periods

  during surgery

• time spent within the desired range of sedation:

  during surgery

• time spent within the desired range of analgesia:

  during surgery

Study Arms (2)

Intervention Group

EXPERIMENTAL

Procedure: anesthesia guided by sedation and analgesia monitoring

Control Group

PLACEBO COMPARATOR

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

Interventions

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

Administration of anesthesia will be performed according to the clinical judgment of the anesthetist as usual practice without sedation and analgesia monitoring

Control Group

anesthesia guided by sedation and analgesia monitoring PROCEDURE

Anesthesia guided by sedation and analgesia monitoring The level of sedation will be monitored by * Monitoring System BIS™ : Bispectral index (BIS) between 45 and 60 AND Suppression Ratio (SR) at 0; * or SedLine® Sedation Monitor : Patient State Index (PSi) between 25 and 50; * or Entropy Sensor™: State entropy (SE) between 45 and 60 AND Burst Suppression Ratio (BSR) at 0; and the level of nociception by : * Nociception monitor PMD-200® : Nociception Level (NoL) between 10 and 25.

Intervention Group

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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;

Sponsors & Collaborators

• Direction Générale de l'Offre de Soins: collaborator
• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (18)

Chu D'Amiens Picardie

Amiens, 80054, France

RECRUITING

Clinique Victor Pauchet

Amiens, 80090, France

RECRUITING

Chru de Besancon

Besançon, 25030, France

NOT YET RECRUITING

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, 33300, France

RECRUITING

Chu Clermont-Ferrand

Clermont-Ferrand, 63000, France

NOT YET RECRUITING

Chu de Grenoble

Grenoble, 38700, France

NOT YET RECRUITING

Chu de Lille

Lille, 59037, France

RECRUITING

APHM - Centre Hôpital Marseille Nord

Marseille, 13015, France

NOT YET RECRUITING

Chu de Nantes

Nantes, 44093, France

NOT YET RECRUITING

Chu de Nimes

Nîmes, 30000, France

RECRUITING

Hopital Bichat Claude Bernard

Paris, 75018, France

RECRUITING

Chu Lyon Sud

Pierre-Bénite, 69495, France

RECRUITING

Chu de Poitiers

Poitiers, 86000, France

RECRUITING

Hôpital Saint Charles

Saint-Dié, 88100, France

NOT YET RECRUITING

Chu St-Etienne

Saint-Etienne, 42100, France

RECRUITING

Chu de Toulouse

Toulouse, 31059, France

RECRUITING

Institut Gustave Roussy

Villejuif, 94800, France

NOT YET RECRUITING

Médipole Lyon Villeurbanne

Villeurbanne, 69100, France

RECRUITING

Study Officials

• David CHARIER, MD, PhD

  CHU DE SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David CHARIER, MD, PhD

CONTACT

+33.4.77.82.85.65; david.charier@chu-st-etienne.fr

Marlène BONNEFOI, CRA

CONTACT

(0)477828822; marlene.bonnefoi@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 7, 2023
• Study Start: October 12, 2023
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (18)