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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)

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 reg...

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Autores principales: Guinot, Pierre-Grégoire, Besch, Guillaume, Hameury, Bastien, Grelet, Tommy, Mertes, Paul Michel, Nguyen, Maxime, Bouhemad, Belaid
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10487869/
https://www.ncbi.nlm.nih.gov/pubmed/37685539
http://dx.doi.org/10.3390/jcm12175473
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author Guinot, Pierre-Grégoire
Besch, Guillaume
Hameury, Bastien
Grelet, Tommy
Mertes, Paul Michel
Nguyen, Maxime
Bouhemad, Belaid
author_facet Guinot, Pierre-Grégoire
Besch, Guillaume
Hameury, Bastien
Grelet, Tommy
Mertes, Paul Michel
Nguyen, Maxime
Bouhemad, Belaid
author_sort Guinot, Pierre-Grégoire
collection PubMed
description 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.
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spelling pubmed-104878692023-09-09 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) Guinot, Pierre-Grégoire Besch, Guillaume Hameury, Bastien Grelet, Tommy Mertes, Paul Michel Nguyen, Maxime Bouhemad, Belaid J Clin Med Protocol 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. MDPI 2023-08-23 /pmc/articles/PMC10487869/ /pubmed/37685539 http://dx.doi.org/10.3390/jcm12175473 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Protocol
Guinot, Pierre-Grégoire
Besch, Guillaume
Hameury, Bastien
Grelet, Tommy
Mertes, Paul Michel
Nguyen, Maxime
Bouhemad, Belaid
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)
title 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)
title_full 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)
title_fullStr 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)
title_full_unstemmed 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)
title_short 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)
title_sort 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)
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10487869/
https://www.ncbi.nlm.nih.gov/pubmed/37685539
http://dx.doi.org/10.3390/jcm12175473
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