Evaluation of Non-opioid Balanced General Anesthesia in Cardiac Surgery With Extracorporeal Circulation: a Randomized, Controlled, Multicenter Superiority Trial
Overview
- Phase
- Phase 3
- Intervention
- Balanced general anesthesia without morphine
- Conditions
- Opioid-free Anesthesia
- Sponsor
- Centre Hospitalier Universitaire Dijon
- Enrollment
- 321
- Locations
- 1
- Primary Endpoint
- Occurrence of at least one postoperative complication
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient who has provided written and informed consent
- •Adult patient
- •Patient undergoing cardiac surgery which is:
- •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
Arms & Interventions
Intervention
Intervention: Balanced general anesthesia without morphine
Intervention
Intervention: Data collection
Intervention
Intervention: Assessment of pain
Intervention
Intervention: Recovery quality score
Controle
Intervention: Standard general anesthesia balanced with morphine
Controle
Intervention: Data collection
Controle
Intervention: Assessment of pain
Controle
Intervention: Recovery quality score
Outcomes
Primary Outcomes
Occurrence of at least one postoperative complication
Time Frame: 30 days post-surgery
Post-operative complications: * postoperative neurological dysfunction * acute renal failure * acute respiratory failure * cardiovascular complications * death