1. Assessment of remifentanil for rapid sequence induction and intubation in patients at risk of pulmonary aspiration of gastric contents compared to rapid-onset paralytic agents: study protocol for a non-inferiority simple blind randomized controlled trial (the REMICRUSH study)
- Author
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Olivier Huet, Alexandra Jobert, Vincent Minville, Jean-Stéphane David, Delphine Flattres-Duchaussoy, Pierre Bouzat, Olivier Langeron, Fanny Feuillet, Marc Danguy des Déserts, Antoine Roquilly, Charlene Le Moal, Celine Lerebourg, Sigismond Lasocki, Nicolas Grillot, Elodie Faurel-Paul, Younes El Amine, Martine Tching-Sin, Nolwenn Chatel-Josse, Raphaël Cinotti, Mathieu Oudot, Karim Asehnoune, Matthias Garot, Nathalie Bruneau, Centre hospitalier universitaire de Nantes (CHU Nantes), CHU Lille, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Neuro-imagerie fonctionnelle et métabolique (ANTE-INSERM U836, équipe 5), Grenoble Institut des Neurosciences (GIN), Université Joseph Fourier - Grenoble 1 (UJF)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Joseph Fourier - Grenoble 1 (UJF)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Valenciennes, Department of Anesthesiology and Critical Care, Hospital Inter-Armée Clermont Tonnerre, Brest, MethodS in Patients-centered outcomes and HEalth ResEarch (SPHERE), Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques, Université de Nantes (UN)-Université de Nantes (UN), and Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques
- Subjects
Adult ,medicine.medical_treatment ,[SDV]Life Sciences [q-bio] ,Remifentanil ,Medicine (miscellaneous) ,Succinylcholine ,law.invention ,03 medical and health sciences ,Study Protocol ,0302 clinical medicine ,Randomized controlled trial ,030202 anesthesiology ,law ,medicine ,Intubation, Intratracheal ,Intubation ,Humans ,Multicenter Studies as Topic ,Pharmacology (medical) ,030212 general & internal medicine ,Rocuronium ,Rapid Sequence Induction and Intubation ,Randomized Controlled Trials as Topic ,Full stomach patient ,Paralytic agents ,lcsh:R5-920 ,business.industry ,Tracheal intubation ,Rapid sequence induction ,medicine.disease ,3. Good health ,Muscle relaxation ,Pulmonary aspiration ,Anesthesia ,business ,lcsh:Medicine (General) ,medicine.drug - Abstract
Background Rapid-onset paralytic agents are recommended to achieve muscle relaxation and facilitate tracheal intubation during rapid sequence induction in patients at risk of pulmonary aspiration of gastric contents. However, opioids are frequently used in this setting. The study’s objective is to demonstrate the non-inferiority of remifentanil compared to rapid-onset paralytic agents, in association with an hypnotic drug, for tracheal intubation in patients undergoing procedure under general anesthesia and at risk of pulmonary aspiration of gastric contents. Methods The REMICRUSH (Remifentanil for Rapid Sequence Induction of Anaesthesia) study is a multicenter, single-blinded, non-inferiority randomized controlled trial comparing remifentanil (3 to 4 μg/kg) with rapid-onset paralytic agents (succinylcholine or rocuronium 1 mg/kg) for rapid sequence induction in 1150 adult surgical patients requiring tracheal intubation during general anesthesia. Enrolment started in October 2019 in 15 French anesthesia units. The expected date of the final follow-up is October 2021. The primary outcome is the proportion of successful tracheal intubation without major complications. A non-inferiority margin of 7% was chosen. Analyses of the intent-to-treat and per-protocol populations are planned. Discussion The REMICRUSH trial protocol has been approved by the ethics committee of The Comité de Protection des Personnes Sud-Ouest et Outre-Mer II and will be carried out according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results of this study will be disseminated through presentations at scientific conferences and publications in peer-reviewed journals. The REMICRUSH trial is the first randomized controlled trial powered to investigate whether remifentanil with hypnotics is non-inferior to rapid-onset paralytic agents with hypnotic in rapid sequence induction of anesthesia for full stomach patients considering successful tracheal intubation without major complication. Trial registration ClinicalTrials.gov NCT03960801. Registered on May 23, 2019.
- Published
- 2021