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

• Status: Recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire Dijon
• Treatments: Anesthetics; Morphine

Criteria

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

• Patients with hypersensitivity to local anesthetics or opiates or to any of the excipients in the products used

• Patients on antidepressants, neuroleptics

• 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

• 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 non-selective MAOIs (iproniazid), selective A MAOIs (moclobemide), selective B MAOIs (selegiline), gabapentin (Neurontin®) or linezolid (Zyvoxid®)

• Patients with severe arterial hypotension (systolic BP<90 mmHg)