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

University Hospital Center (CHU) Dijon Bourgogne

Status and phase: Completed; Phase 3

Conditions: Cardiac Surgery; Opioid-free Anesthesia

Treatments: Other: Data collection; Drug: Standard general anesthesia balanced with morphine; Other: Assessment of pain; Other: Recovery quality score; Drug: Balanced general anesthesia without morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT04886453

BOUHEMAD PHRCI 2019

Details and patient eligibility

About

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

Enrollment: 321 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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321 participants in 2 patient groups

Intervention

Experimental group

Treatment:

Other: Recovery quality score

Other: Assessment of pain

Drug: Balanced general anesthesia without morphine

Other: Data collection

Controle

Active Comparator group

Treatment:

Other: Recovery quality score

Other: Assessment of pain

Other: Data collection

Drug: Standard general anesthesia balanced with morphine