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

Phase 3

Completed

• Conditions: Opioid-free Anesthesia; Cardiac Surgery
• Interventions: Drug: Balanced general anesthesia without morphine; Drug: Standard general anesthesia balanced with morphine; Other: Data collection; Other: Assessment of pain; Other: Recovery quality score

• Registration Number: NCT04886453
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-10
• Study First Submitted QC: 2021-05-10
• Study First Posted: 2021-05-14
• Study Start: 2021-08-30
• Primary Completion: 2024-03-21
• Study Completion: 2024-03-21
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Balanced general anesthesia without morphine	-
Intervention	Data collection	-
Intervention	Assessment of pain	-
Intervention	Recovery quality score	-
Controle	Standard general anesthesia balanced with morphine	-
Controle	Data collection	-
Controle	Assessment of pain	-
Controle	Recovery quality score	-

Primary Outcome Measures

Name	Time	Method
Occurrence of at least one postoperative complication	30 days post-surgery	Post-operative complications: * postoperative neurological dysfunction; * acute renal failure; * acute respiratory failure; * cardiovascular complications; * death

Trial Locations

Locations (1)

Chu Dijon Bourgogne; 🇫🇷 Dijon, France