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RECRUITING
NCT05893030
NA

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

Sponsor: Centre Hospitalier Universitaire de Saint Etienne

View on ClinicalTrials.gov

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.

Official title: Prevention of Organ Dysfunction and Mortality by Monitoring the Administration of Opioids and Hypnotics in Patients at High Postoperative Risk: the Opti-Two Study. A Multi-center Controlled Randomized Study.

Key Details

Gender

All

Age Range

75 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1132

Start Date

2023-10-12

Completion Date

2028-02

Last Updated

2026-02-17

Healthy Volunteers

No

Interventions

PROCEDURE

anesthesia guided by sedation and analgesia monitoring

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.

PROCEDURE

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

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

Locations (18)

Chu D'Amiens Picardie

Amiens, France

Clinique Victor Pauchet

Amiens, France

Chru de Besancon

Besançon, France

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, France

Chu Clermont-Ferrand

Clermont-Ferrand, France

Chu de Grenoble

Grenoble, France

Chu de Lille

Lille, France

APHM - Centre Hôpital Marseille Nord

Marseille, France

Chu de Nantes

Nantes, France

Chu de Nimes

Nîmes, France

Hopital Bichat Claude Bernard

Paris, France

Chu Lyon Sud

Pierre-Bénite, France

Chu de Poitiers

Poitiers, France

Hôpital Saint Charles

Saint-Dié, France

Chu St-Etienne

Saint-Etienne, France

Chu de Toulouse

Toulouse, France

Institut Gustave Roussy

Villejuif, France

Médipole Lyon Villeurbanne

Villeurbanne, France