Evaluation of Non-opioid Balanced General Anesthesia in Cardiac Surgery With Extracorporeal Circulation: a Randomized, Controlled, Multicenter Superiority Trial

BOUHEMAD PHRCI 2019

Opioid-free anesthesia (OFA) is a general anesthesia based on the use of hypnotics and non-opioid analgesics (lidocaine, ketamine, dexamethasone, esmolol). This technique has been used for the past 10 years, during which randomized and non-randomized studies have demonstrated a number of positive effects on cardiac function: * better analgesia and decreased postoperative morphine consumption, * better respiratory function, * better hemodynamic stability, * better postoperative cognitive function. The hypothesis of the present study is that the use of OFA during cardiac surgery is associated with: * Improved intraoperative hemodynamic stability * A decrease in the incidence of postoperative complications * A reduction in intensive care and hospital length of stay

2021-08-30

2024-03-21

2024-03-21

Completed

Early phase I

321

Inclusion Criteria: * Patient who has provided written and informed consent * Adult patient * Patient undergoing cardiac surgery which is: 1. Scheduled 2. With bypass surgery 3. Of the following types: aortic valve surgery, mitral valve surgery, tricuspid valve surgery, atrial myxoma, coronary artery bypass surgery, aortic surgery, combined surgery Exclusion Criteria: * Person not affiliated to national health insurance * Person under legal protection (curatorship, guardianship) * Person under court order * Pregnant or breastfeeding woman * Adult unable to express consent * Patient already included once in the study * Patient requiring emergency surgery within 24 hours * Patients with hypersensitivity to local anesthetics or opiates or to any of the excipients in the products used * Patients on antidepressants, neuroleptics such as non-selective MAOIs (iproniazid), selective A MAOI (moclobemide), selective B MAOI (selegiline) gabapentin (Neurontin®) * Patients with an unprotected atrioventricular conduction disorder * Patients with a prolonged QTc (\> 450 ms) on preoperative ECG * Patient with severe liver failure (PT\< 30%) * Patient suffering from respiratory failure (Long-term oxygen therapy patient except OSA) * Patient with uncontrolled epilepsy * Patient with preoperative cognitive dysfunction (MMS \<24) * Patient with intracranial hypertension * Patient with chronic kidney failure (dialysis, creatinine \> 200 μmol L-1) * Patient with porphyria * Patients treated with linezolid (Zyvoxid®) * Patients with severe arterial hypotension (systolic BP\<90 mmHg)

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2024-05-17