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.

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.

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.