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

Study Overview
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Brief Summary
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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

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

Conditions
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Opioid-free Anesthesia, Cardiac Surgery

Intervention / Treatment
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* Drug: Balanced general anesthesia without morphine
* Drug: Standard general anesthesia balanced with morphine
* Other: Data collection
* Other: Assessment of pain
* Other: Recovery quality score


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient who has provided written and informed consent Adult patient Patient undergoing cardiac surgery which is: Scheduled With bypass surgery 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Drug: Balanced general anesthesia without morphine<br>* Balanced general anesthesia without morphine<br>Other: Data collection<br>* Data collection<br>Other: Assessment of pain<br>* visual analog scale<br>Other: Recovery quality score<br>* QoR15 questionnaire<br>|
| Active Comparator: Controle<br> | Drug: Standard general anesthesia balanced with morphine<br>* Standard general anesthesia balanced with morphine<br>Other: Data collection<br>* Data collection<br>Other: Assessment of pain<br>* visual analog scale<br>Other: Recovery quality score<br>* QoR15 questionnaire<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of at least one postoperative complication | Post-operative complications: postoperative neurological dysfunction acute renal failure acute respiratory failure cardiovascular complications death | 30 days post-surgery |