Informations générales (source: ClinicalTrials.gov)

NCT05893030 En recrutement IDF
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.
Interventional
N/A
Centre Hospitalier Universitaire de Saint Etienne (Voir sur ClinicalTrials)
octobre 2023
février 2028
02 mars 2026
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.
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Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
CLCC INSTITUT GUSTAVE ROUSSY Cyrus MOTAMED En recrutement IDF 27/04/2026 09:30:07 Contact (sur clinicalTrials)
Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
IFSI-IFAS DU CH BICHAT-CLAUDE BERNARD Contact (sur clinicalTrials)
Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
APHM - Centre Hôpital Marseille Nord - 13015 - Marseille 2995469 - France Contact (sur clinicalTrials)
Chru de Besancon - 25030 - Besançon 3033123 - France Contact (sur clinicalTrials)
Chu D'Amiens Picardie - 80054 - Amiens 3037854 - France Contact (sur clinicalTrials)
Chu de Grenoble - 38700 - Grenoble 3014728 - France Contact (sur clinicalTrials)
Chu de Nantes - 44093 - Nantes 2990969 - France Contact (sur clinicalTrials)
Chu de Poitiers - 86000 - Poitiers 2986495 - France Contact (sur clinicalTrials)
Chu de Toulouse - 31059 - Toulouse 2972315 - France Contact (sur clinicalTrials)
Chu Lyon Sud - 69495 - Pierre-Bénite 2987314 - France Contact (sur clinicalTrials)
Chu St-Etienne - 42100 - Saint-Etienne 2980291 - France Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Chu Clermont-Ferrand - 63000 - Clermont-Ferrand 3024635 - France Contact (sur clinicalTrials)
Chu de Lille - 59037 - Lille 2998324 - France Contact (sur clinicalTrials)
Chu de Nimes - 30000 - Nîmes 2990363 - France Contact (sur clinicalTrials)
Clinique Victor Pauchet - 80090 - Amiens 3037854 - France Contact (sur clinicalTrials)
Hôpital Saint Charles - 88100 - Saint-Dié 2980827 - France Contact (sur clinicalTrials)
Médipole Lyon Villeurbanne - 69100 - Villeurbanne 2968254 - France Contact (sur clinicalTrials)
Polyclinique Bordeaux Nord Aquitaine - 33300 - Bordeaux 3031582 - France Contact (sur clinicalTrials)

Critères

Tous
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.