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Protocol Study for the Evaluation of Non-Opioid Balanced General Anaesthesia in Cardiac Surgery with Cardiopulmonary Bypass: A Randomised, Controlled, Multicentric Superiority Trial (OFACAR Study)

Authors :
Pierre-Grégoire Guinot
Guillaume Besch
Bastien Hameury
Tommy Grelet
Paul Michel Mertes
Maxime Nguyen
Belaid Bouhemad
on behalf of the OFACAR Study Group
Source :
Journal of Clinical Medicine, Vol 12, Iss 17, p 5473 (2023)
Publication Year :
2023
Publisher :
MDPI AG, 2023.

Abstract

Opioid-free anaesthesia (OFA) is general anaesthesia based on the use of several non-opioid molecules that aim to have an analgesic effect, decrease the sympathetic response, decrease hormonal stress, and decrease the inflammatory response during surgery. Although this approach to anaesthesia is regularly used in clinical practice, it remains a novel approach. The literature on this anaesthesia modality finds a number of positive effects on cardiac, respiratory, and cognitive function but no randomised study evaluated these effects during cardiac surgery where there is a high incidence of postoperative complications. The main aim of the study is to compare OFA vs. standard balanced opioid general anaesthesia on the incidence of postoperative complications and the length of stay in intensive care and hospital. OFACAR is a multicentric, randomised, controlled, superiority, single-blind, two parallel-arm clinical trial in patients undergoing cardiac surgery with cardiopulmonary bypass. We compared a balanced general anaesthesia without opioids (OFA group) vs. a balanced opioid general anaesthesia with sufentanil (control group). One hundred and sixty patients will be enrolled in each treatment group. The primary endpoint is a composite one which corresponds to the occurrence of at least one of the postoperative complications, defined according to European standards within 30 days after surgery. Recruitment started in September 2019, and data collection is expected to end in November 2024.

Details

Language :
English
ISSN :
20770383
Volume :
12
Issue :
17
Database :
Directory of Open Access Journals
Journal :
Journal of Clinical Medicine
Publication Type :
Academic Journal
Accession number :
edsdoj.59ce14a9e9cf4ea6ae1cf8982f844a69
Document Type :
article
Full Text :
https://doi.org/10.3390/jcm12175473