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. 2021 Mar 30;22(1):237.
doi: 10.1186/s13063-021-05192-x.

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)

Nicolas Grillot  1 , Matthias Garot  2 , Sigismond Lasocki  3 , Olivier Huet  4 , Pierre Bouzat  5 , Charlène Le Moal  6 , Mathieu Oudot  7 , Nolwenn Chatel-Josse  8 , Younes El Amine  9 , Marc Danguy des Déserts  10 , Nathalie Bruneau  11 , Raphael Cinotti  12 , Jean-Stéphane David  13 , Olivier Langeron  14 , Vincent Minville  15 , Martine Tching-Sin  16 , Elodie Faurel-Paul  17 , Céline Lerebourg  18 , Delphine Flattres-Duchaussoy  18 , Alexandra Jobert  17 , Karim Asehnoune  18 , Fanny Feuillet  19   20 , Antoine Roquilly  18
Affiliations

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)

Nicolas Grillot et al. Trials. .

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.

Keywords: Full stomach patient; Paralytic agents; Rapid sequence induction; Remifentanil; Rocuronium; Succinylcholine; Tracheal intubation.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
CONSORT diagram of the Remifentanil for Rapid Sequence Induction of Anaesthesia (REMICRUSH) trial illustrating the randomization and flow of patients in the study
Fig. 2
Fig. 2
Data collection timeline for the REMICRUSH study. FeO2, fractional expired oxygen concentration, ROP, Rapid-Onset Paralytic Agent
See this image and copyright information in PMC

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