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Opioid-free anaesthesia with dexmedetomidine and lidocaine versus remifentanil-based anaesthesia in cardiac surgery: study protocol of a French randomised, multicentre and single-blinded OFACS trial.
- Source :
-
BMJ open [BMJ Open] 2024 Jun 03; Vol. 14 (6), pp. e079984. Date of Electronic Publication: 2024 Jun 03. - Publication Year :
- 2024
-
Abstract
- Introduction: Intraoperative opioids have been used for decades to reduce negative responses to nociception. However, opioids may have several, and sometimes serious, adverse effects. Cardiac surgery exposes patients to a high risk of postoperative complications, some of which are common to those caused by opioids: acute respiratory failure, postoperative cognitive dysfunction, postoperative ileus (POI) or death. An opioid-free anaesthesia (OFA) strategy, based on the use of dexmedetomidine and lidocaine, may limit these adverse effects, but no randomised trials on this issue have been published in cardiac surgery.We hypothesised that OFA versus opioid-based anaesthesia (OBA) may reduce the incidence of major opioid-related complications after cardiac surgery.<br />Methods and Analysis: Multicentre, randomised, parallel and single-blinded clinical trial in four cardiac surgical centres in France, including 268 patients scheduled for coronary artery bypass grafting under cardiac bypass, with or without aortic valve replacement. Patients will be randomised to either a control OBA protocol using remifentanil or an OFA protocol using dexmedetomidine/lidocaine. The primary composite endpoint is the occurrence of at least one of the following: (1) postoperative cognitive disorder evaluated by the Confusion Assessment Method for the Intensive Care Unit test, (2) POI, (3) acute respiratory distress or (4) death within the first 48 postoperative hours. Secondary endpoints are postoperative pain, morphine consumption, nausea-vomiting, shock, acute kidney injury, atrioventricular block, pneumonia and length of hospital stay.<br />Ethics and Dissemination: This trial has been approved by an independent ethics committee ( Comité de Protection des Personnes Ouest III-Angers on 23 February 2021). Results will be submitted in international journals for peer reviewing.<br />Trial Registration Number: NCT04940689, EudraCT 2020-002126-90.<br />Competing Interests: Competing interests: None declared.<br /> (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
- Subjects :
- Humans
France
Multicenter Studies as Topic
Pain, Postoperative drug therapy
Pain, Postoperative prevention & control
Postoperative Complications prevention & control
Randomized Controlled Trials as Topic
Single-Blind Method
Analgesics, Opioid therapeutic use
Cardiac Surgical Procedures adverse effects
Cardiac Surgical Procedures methods
Dexmedetomidine therapeutic use
Lidocaine therapeutic use
Remifentanil administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 2044-6055
- Volume :
- 14
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- BMJ open
- Publication Type :
- Academic Journal
- Accession number :
- 38830745
- Full Text :
- https://doi.org/10.1136/bmjopen-2023-079984