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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
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
Conditions
Interventions
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.
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