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, Matthias Garot, Sigismond Lasocki, Olivier Huet, Pierre Bouzat, Charlène Le Moal, Mathieu Oudot, Nolwenn Chatel-Josse, Younes El Amine, Marc Danguy des Déserts, Nathalie Bruneau, Raphael Cinotti, Jean-Stéphane David, Olivier Langeron, Vincent Minville, Martine Tching-Sin, Elodie Faurel-Paul, Céline Lerebourg, Delphine Flattres-Duchaussoy, Alexandra Jobert, Karim Asehnoune, Fanny Feuillet, Antoine Roquilly, Nicolas Grillot, Matthias Garot, Sigismond Lasocki, Olivier Huet, Pierre Bouzat, Charlène Le Moal, Mathieu Oudot, Nolwenn Chatel-Josse, Younes El Amine, Marc Danguy des Déserts, Nathalie Bruneau, Raphael Cinotti, Jean-Stéphane David, Olivier Langeron, Vincent Minville, Martine Tching-Sin, Elodie Faurel-Paul, Céline Lerebourg, Delphine Flattres-Duchaussoy, Alexandra Jobert, Karim Asehnoune, Fanny Feuillet, Antoine Roquilly

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.

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

References

    1. Reynolds SF, Heffner J. Airway management of the critically ill patient: rapid-sequence intubation. Chest. 2005;127(4):1397–1412.
    1. Orebaugh SL. Succinylcholine: adverse effects and alternatives in emergency medicine. Am J Emerg Med. 1999;17(7):715–721. doi: 10.1016/S0735-6757(99)90168-7.
    1. Tran DT, Newton EK, Mount VA, Lee JS, Wells GA, Perry JJ. Rocuronium versus succinylcholine for rapid sequence induction intubation. Cochrane Database Syst Rev. 2015;2015(10):CD002788. 10.1002/14651858.CD002788.pub3.
    1. Reddy JI, Cooke PJ, van Schalkwyk JM, Hannam JA, Fitzharris P, Mitchell SJ. Anaphylaxis is more common with rocuronium and succinylcholine than with atracurium. Anesthesiology. 2015;122(1):39–45. doi: 10.1097/ALN.0000000000000512.
    1. Jaber S, Amraoui J, Lefrant J-Y, Arich C, Cohendy R, Landreau L, et al. Clinical practice and risk factors for immediate complications of endotracheal intubation in the intensive care unit: a prospective, multiple-center study. Crit Care Med. 2006;34(9):2355–2361. doi: 10.1097/01.CCM.0000233879.58720.87.
    1. Simpson GD, Ross MJ, McKeown DW, Ray DC. Tracheal intubation in the critically ill: a multi-centre national study of practice and complications. Br J Anaesth. 2012;108(5):792–799. doi: 10.1093/bja/aer504.
    1. Landreau B, Odin I, Nathan N. Pulmonary aspiration: epidemiology and risk factors. Ann Fr Anesth Reanim. 2009;28(3):206–210. doi: 10.1016/j.annfar.2009.01.020.
    1. Sajayan A, Wicker J, Ungureanu N, Mendonca C, Kimani PK. Current practice of rapid sequence induction of anaesthesia in the U.K. - a national survey. Br J Anaesth. 2016;117(Suppl 1):i69–i74. doi: 10.1093/bja/aew017.
    1. Rosow C. Remifentanil: a unique opioid analgesic. Anesthesiology. 1993;79(5):875–876.
    1. Erhan E, Ugur G, Alper I, Gunusen I, Ozyar B. Tracheal intubation without muscle relaxants: remifentanil or alfentanil in combination with propofol. Eur J Anaesthesiol. 2003;20(1):37–43. doi: 10.1097/00003643-200301000-00007.
    1. Bouvet L, Stoian A, Rimmelé T, Allaouchiche B, Chassard D, Boselli E. Optimal remifentanil dosage for providing excellent intubating conditions when co-administered with a single standard dose of propofol. Anaesthesia. 2009;64(7):719–726. doi: 10.1111/j.1365-2044.2009.05916.x.
    1. McNeil IA, Culbert B, Russell I. Comparison of intubating conditions following propofol and succinylcholine with propofol and remifentanil 2 micrograms kg-1 or 4 micrograms kg-1. Br J Anaesth. 2000;85(4):623–625. doi: 10.1093/bja/85.4.623.
    1. Stevens JB, Wheatley L. Tracheal intubation in ambulatory surgery patients: using remifentanil and propofol without muscle relaxants. Anesth Analg. 1998;86(1):45–49.
    1. Demirkaya M, Kelsaka E, Sarihasan B, Bek Y, Üstün E. The optimal dose of remifentanil for acceptable intubating conditions during propofol induction without neuromuscular blockade. J Clin Anesth. 2012;24(5):392–7. 10.1016/j.jclinane.2011.11.006.
    1. Langeron O, Bourgain JL, Francon D, Amour J, Baillard C, Bouroche G, et al. Difficult intubation and extubation in anaesthesia in the adult patient. Anesthesiol Reanim. 2017;3:552–571.
    1. Futier E, Lefrant JY, Guinot PG, Godet T, Lorne E, Cuvillon P, et al. Effect of individualized vs standard blood pressure management strategies on postoperative organ dysfunction among high-risk patients undergoing major surgery: a randomized clinical trial. JAMA. 2017;318(14):1346–1357. doi: 10.1001/jama.2017.14172.
    1. Agarwal A, Nath SS, Goswami D, Gupta D, Dhiraaj S, Singh PK. An evaluation of the efficacy of aspirin and benzydamine hydrochloride gargle for attenuating postoperative sore throat: a prospective, randomized, single-blind study. Anesth Analg. 2006;103(4):1001–1003. doi: 10.1213/01.ane.0000231637.28427.00.
    1. Plaud B, Baillard C, Bourgain JL, Bouroche G, Desplanque L, Devys JM, Fletcher D, Fuchs-Buder T, Lebuffe G, Meistelman C, Motamed C, Raft J, Servin F, Sirieix D, Slim K, Velly L, Verdonk F, Debaene B. Guidelines on muscle relaxants and reversal in anaesthesia. Anaesth Crit Care Pain Med. 2020;39(1):125-42. 10.1016/j.accpm.2020.01.005. Epub 2020 Jan 8.
    1. Ono Y, Kakamu T, Kikuchi H, Mori Y, Watanabe Y, Shinohara K. Expert-performed endotracheal intubation-related complications in trauma patients: incidence, possible risk factors, and outcomes in the prehospital setting and emergency department. Emerg Med Int. 2018;10:5649476.
    1. Langeron O, Amour J, Vivien B, Aubrun F. Clinical review: management of difficult airways. Crit Care. 2006;10(6):243. doi: 10.1186/cc5112.
    1. Juvin P, Lavaut E, Dupont H, Lefevre P, Demetriou M, Dumoulin JL, et al. Difficult tracheal intubation is more common in obese than in lean patients. Anesth Analg. 2003;97(2):595–600. doi: 10.1213/01.ANE.0000072547.75928.B0.
    1. Le Henanff A, Giraudeau B, Baron G, Ravaud P. Quality of reporting of non-inferiority and equivalence randomized trials. JAMA. 2006;295(10):1147–1151. doi: 10.1001/jama.295.10.1147.
    1. Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG. Reporting of non-inferiority and equivalence randomized trials: an extension of the CONSORT 2010 statement. JAMA. 2012;308:2594–2604. doi: 10.1001/jama.2012.87802.
    1. Mauri L, D’Agostino RB. Challenges in the design and interpretation of noninferiority trials. N Engl J Med. 2017;377:1357–1367. doi: 10.1056/NEJMra1510063.
    1. Sakai T, Planinsic RM, Quinlan JJ, Handley LJ, Kim TY, Hilmi IA. The incidence and outcome of perioperative pulmonary aspiration in a university hospital: a 4-year retrospective analysis. Anesth Analg. 2006;103:941–947. doi: 10.1213/01.ane.0000237296.57941.e7.
    1. Diemunsch P, Langeron O, Richard M, Lenfant F. Prediction and definition of difficult mask ventilation and difficult intubation: question 1. Société Française d'Anesthésie et de Réanimation. Ann Fr Anesth Reanim. 2008;27(1):3–14. doi: 10.1016/j.annfar.2007.10.028.
    1. Quintard H, l'Her E, Pottecher J, Adnet F, Constantin JM, De Jong A, et al. Intubation and extubation of the ICU patient. Anaesth Crit Care Pain Med. 2017;36(5):327–341. doi: 10.1016/j.accpm.2017.09.001.
    1. Jaber S, Jung B, Corne P, Sebbane M, Muller L, Chanques G, et al. An intervention to decrease complications related to endotracheal intubation in the intensive care unit: a prospective, multiple-center study. Intensive Care Med. 2010;36(2):248–255. doi: 10.1007/s00134-009-1717-8.
    1. Kirmeier E, Eriksson LI, Lewald H, Jonsson Fagerlund M, Hoeft A, Hollmann M, et al. Post-anaesthesia pulmonary complications after use of muscle relaxants (POPULAR): a multicentre, prospective observational study. Lancet Respir Med. 2019;7(2):129–140. doi: 10.1016/S2213-2600(18)30294-7.

Source: PubMed

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

3
Abonnieren