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BMJ Open. 2018 Jun 30;8(6):e020873. doi: 10.1136/bmjopen-2017-020873.

POFA trial study protocol: a multicentre, double-blind, randomised, controlled clinical trial comparing opioid-free versus opioid anaesthesia on postoperative opioid-related adverse events after major or intermediate non-cardiac surgery.

Author information

1
CHU Rennes, Pôle Anesthésie et Réanimation, Inserm, NuMeCan, CIC 1414 and Université de Rennes 1, Rennes, France.
2
Univ Rennes, CHU Rennes, Inserm, CIC 1414 (Centre d'investigation clinique de Rennes, service de pharmacologie clinique), Rennes, France.
3
CHU de Rennes, Pôle de Biologie, Rennes, France.
4
INSERM, UMR U1236, Université Rennes 1, EFS Bretagne, Rennes, France.
5
Département Anesthésie Réanimation, Assistance publique-Hôpitaux de Paris (AP-HP), Hôpital Beaujon, Hôpitaux Universitaires Paris Nord Val de Seine, and Université Paris Diderot, Clichy, France.
6
Centre Hospitalier Universitaire (CHU) Lille, Pôle Anesthesie Réanimation, Lille, France.
7
Department of Anesthesiology and Critical Care Medicine, Centre hospitalier universitaire (CHU) de Nantes, Nantes, France.
8
Département d'Anesthésie et de Réanimation, Centre Hospitalier et Universitaire de Toulouse, Toulouse, France.
9
Service Anesthésie, Pôle Anesthésie Réanimation Douleur Urgence, Centre Hospitalier Universitaire Carémeau, Nimes, France.
10
Centre Hospitalier de Périgueux, Pôle Bloc Anesthésie Chirurgie, Service d'anesthésiologie, Perigueux, France.
11
Centre Hospitalier Metz Thionville, Pôle Anesthesie Réanimation, Metz, France.
12
Centre Hospitalier Yves le Foll, Pôle Anesthesie Réanimation, Saint-Brieuc, France.
13
Department of Anaesthesia and Critical Care Medicine, University of Montpellier Saint Eloi Hospital, PhyMedExp, University of Montpellier, Montpellier, France.
14
Département de Médecine Périopératoire, Université Clermont Auvergne, GreD, CNRS, Inserm U1103, Centre Hospitalier Universitaire (CHU) Clermont-Ferrand, Clermont-Ferrand, France.

Abstract

INTRODUCTION:

Reducing opioid consumption during and after surgery has been recommended for more than 10 years. Opioid-free anaesthesia (OFA) is a multimodal anaesthesia associating hypnotics, NMDA antagonists, local anaesthetics, anti-inflammatory drugs and α-2 agonists. Proofs of the effect of OFA on reducing opioid-related adverse effects after major or intermediate non-cardiac surgery are still scarce. We hypothesised that the reduced opioid consumption allowed by OFA compared with standard of care will be associated with a reduction of postoperative opioid-related adverse events.

METHODS/ANALYSIS:

The POFA trial is a prospective, randomised, parallel, single-blind, multicentre study of 400 patients undergoing elective intermediate or major non-cardiac surgery. Patients will be randomly allocated to receive either a standard anaesthesia protocol or an OFA. The primary outcome measure is the occurrence of a severe postoperative opioid-related adverse event within the first 48 hours after extubation defined as: postoperative hypoxaemia or postoperative ileus or postoperative cognitive dysfunction. In addition, each component of the primary outcome measure will be analysed separately. Data will be analysed on the intention-to-treat principle and a per-protocol basis.

ETHICS AND DISSEMINATION:

The POFA trial has been approved by an independent ethics committee for all study centres. Participant recruitment begins in November 2017. Results will be published in international peer-reviewed medical journals.

TRIAL REGISTRATION NUMBER:

NCT03316339; Pre-results.

KEYWORDS:

opioid; opioid-free anesthesia; remifentanil

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