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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 • ClinicalTrials.gov ID: NCT05893030

Registry updated: 2026-10-08

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Description

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.

Interventions

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.
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

Eligibility criteria

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; * complete arrhythmia due to atrial fibrillation; * acute respiratory failure or pneumonia; * septic shock; * acute stroke; * cardiac surgery; * open chest surgery; * opioid free anesthesia; * intraoperative ketamine at a dose \> 0.25 mg.kg-1; \> 0.25 mg/kg or or intravenous electric syringe * lidocaine or dexmedetomidine by continuous infusion; * refusal to participate in the study; * patient under guardianship, conservatorship, or unable to understand the study.

Conditions

Sedation and Analgesia Monitoring

Locations

Chu D'Amiens Picardie — Amiens, France
Clinique Victor Pauchet — Amiens, France
Chru de Besancon — Besançon, France
Polyclinique Bordeaux Nord Aquitaine — Bordeaux, France
Hôpital de La Cavale Blanche — Brest, 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
Hôpital l'Archet — Nice, 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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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