RecruitingNot ApplicableNCT05893030

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

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.


Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Enrollment

1,132 participants

Start Date

Oct 12, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 75 Years

Inclusion Criteria30

  • 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
  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREanesthesia 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.

PROCEDUREanesthesia 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05893030