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

NARecruitingINTERVENTIONAL
Enrollment

1,132

Participants

Timeline

Start Date

October 12, 2023

Primary Completion Date

January 31, 2027

Study Completion Date

December 31, 2027

Conditions
Sedation and Analgesia Monitoring
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

Trial Locations (14)

13015

NOT_YET_RECRUITING

APHM - Centre Hôpital Marseille Nord, Marseille

25030

NOT_YET_RECRUITING

Chru de Besancon, Besançon

30000

NOT_YET_RECRUITING

Chu de Nimes, Nîmes

31059

NOT_YET_RECRUITING

Chu de Toulouse, Toulouse

38700

NOT_YET_RECRUITING

Chu de Grenoble, Grenoble

42100

RECRUITING

Chu St-Etienne, Saint-Etienne

44093

NOT_YET_RECRUITING

Chu de Nantes, Nantes

59037

NOT_YET_RECRUITING

Chu de Lille, Lille

63000

NOT_YET_RECRUITING

Chu Clermont-Ferrand, Clermont-Ferrand

69100

NOT_YET_RECRUITING

Médipole Lyon Villeurbanne, Villeurbanne

69495

NOT_YET_RECRUITING

Chu Lyon Sud, Pierre-Bénite

75018

NOT_YET_RECRUITING

Hopital Bichat Claude Bernard, Paris

80054

NOT_YET_RECRUITING

Chu D'Amiens Picardie, Amiens

86000

NOT_YET_RECRUITING

Chu de Poitiers, Poitiers

All Listed Sponsors
collaborator

Direction Générale de l'Offre de Soins

OTHER_GOV

lead

Centre Hospitalier Universitaire de Saint Etienne

OTHER