Abstract
BackgroundRapid-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.MethodsThe 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.DiscussionThe 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 registrationClinicalTrials.gov NCT03960801. Registered on May 23, 2019.
Highlights
Pulmonary aspiration of gastric contents is a severe complication related to general anesthesia, whose incidence increases in patients with a full stomach
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
Hypothesis The incidence of major complications during the tracheal intubation of patients at risk of pulmonary aspiration of gastric contents is not increased by remifentanil use, as a replacement for rapid-onset paralytic agents, in intravenous rapid sequence induction and intubation
Summary
Pulmonary aspiration of gastric contents is a severe complication related to general anesthesia, whose incidence increases in patients with a full stomach. Rapid sequence induction is recommended for patients at risk of pulmonary aspiration of gastric contents (for example, emergency procedure, bowel obstruction, obese patients, or severe gastroesophageal reflux). Standard rapid sequence induction relies on the combination of a rapid hypnotic drug with a rapid-onset paralytic agent In this setting, succinylcholine is recommended as the rapid-onset paralytic agent of first intention [1]. 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. 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
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