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

February 19, 2024 updated by: Centre Hospitalier Universitaire Dijon

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

320

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2021

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

May 10, 2021

First Submitted That Met QC Criteria

May 10, 2021

First Posted (Actual)

May 14, 2021

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BOUHEMAD PHRCI 2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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