Bertrand Guihard1, Charlotte Chollet-Xémard2, Philippe Lakhnati3, Benoit Vivien4, Claire Broche5, Dominique Savary6, Agnes Ricard-Hibon7, Pierre-Jean Marianne Dit Cassou8, Frédéric Adnet9, Eric Wiel10,11,12, Juliette Deutsch13, Cindy Tissier14, Thomas Loeb15, Vincent Bounes16,17, Emmanuel Rousseau18, Patricia Jabre19, Laetitia Huiart20,21, Cyril Ferdynus22, Xavier Combes23. 1. Department of Emergency, CHU de la Réunion, Allée des Topazes, Saint Denis, Réunion, France. 2. Groupe Hospitalo-Universitaire Henri Mondor, SAMU 94, Assistance Publique-Hôpitaux de Paris, Créteil, France. 3. SMUR 95, Centre Hospitalier de Gonesse, Gonesse, France. 4. Department of Anesthesia & Critical Care - SAMU, Assistance Publique - Hôpitaux de Paris, Hôpital Necker-Enfants Malades, Université Paris Descartes, Paris, France. 5. Département d'Anesthésie-Réanimation-SMUR, Hôpital Universitaire Lariboisière, AP-HP, Paris, France. 6. Emergency Department, General Hospital of Annecy, Annecy, France. 7. SMUR de l'hôpital Beaujon, Clichy, France. 8. Department of Emergency, CHU de la Réunion, Réunion, France. 9. AP-HP, Urgences-SAMU 93, Unité Recherche-Enseignement-Qualité, Hôpital Avicenne, Bobigny, France. 10. Univ Lille, EA 2694 - Santé Publique: Epidémiologie et Qualité des Soins, Lille, France. 11. French National Out-of-Hospital Cardiac Arrest Registry Research Group - Registre électronique des Arrêts Cardiaques, Lille, France. 12. Emergency Medicine Department and SAMU 59, Lille University Hospital, Lille, France. 13. Department of Emergency Medicine, Groupe Hospitalier Broca Cochin Hôtel-Dieu, Paris, France. 14. Department of Emergency Medicine, University Hospital Dijon, Dijon, France. 15. Raymond Poincaré Hospital (APHP), SAMU 92, Paris, France. 16. Pôle Médecine d'Urgence, Hôpital Universitaire de Purpan, Toulouse, France. 17. INSERM UMR 1027, Université Paul Sabatier, Toulouse, France. 18. Services de Médecine d'Urgence et de Réanimation, Pôle Urgence Réanimation, SAMU 77, Melun, France. 19. AP-HP, Service d'Aide Médicale d'Urgence (SAMU) de Paris and Paris Sudden Death Expertise Center, Université Paris Descartes, Paris, France. 20. INSERM CIC 1410 Clinical and Epidemiology/ CHU Réunion/Université de la Réunion, Saint-Pierre, Reunion, France. 21. Department of Population Health, Luxembourg Institute of Health, Strassen, Luxembourg. 22. Departement d'Informatique Clinique, Centre Hospitalier Universitaire de La Réunion Site Félix Guyon, Saint-Denis, France. 23. Department of Emergency, CHU de la Réunion, Université de la Réunion, Réunion, France.
Abstract
Importance: Rocuronium and succinylcholine are often used for rapid sequence intubation, although the comparative efficacy of these paralytic agents for achieving successful intubation in an emergency setting has not been evaluated in clinical trials. Succinylcholine use has been associated with several adverse events not reported with rocuronium. Objective: To assess the noninferiority of rocuronium vs succinylcholine for tracheal intubation in out-of-hospital emergency situations. Design, Setting and Participants: Multicenter, single-blind, noninferiority randomized clinical trial comparing rocuronium (1.2 mg/kg) with succinylcholine (1 mg/kg) for rapid sequence intubation in 1248 adult patients needing out-of-hospital tracheal intubation. Enrollment occurred from January 2014 to August 2016 in 17 French out-of-hospital emergency medical units. The date of final follow-up was August 31, 2016. Interventions: Patients were randomly assigned to undergo tracheal intubation facilitated by rocuronium (n = 624) or succinylcholine (n = 624). Main Outcomes and Measures: The primary outcome was the intubation success rate on first attempt. A noninferiority margin of 7% was chosen. A per-protocol analysis was prespecified as the primary analysis. Results: Among 1248 patients who were randomized (mean age, 56 years; 501 [40.1%] women), 1230 (98.6%) completed the trial and 1226 (98.2%) were included in the per-protocol analysis. The number of patients with successful first-attempt intubation was 455 of 610 (74.6%) in the rocuronium group vs 489 of 616 (79.4%) in the succinylcholine group, with a between-group difference of -4.8% (1-sided 97.5% CI, -9% to ∞), which did not meet criteria for noninferiority. The most common intubation-related adverse events were hypoxemia (55 of 610 patients [9.0%]) and hypotension (39 of 610 patients [6.4%]) in the rocuronium group and hypoxemia (61 of 616 [9.9%]) and hypotension (62 of 616 patients [10.1%]) in the succinylcholine group. Conclusions and Relevance: Among patients undergoing endotracheal intubation in an out-of-hospital emergency setting, rocuronium, compared with succinylcholine, failed to demonstrate noninferiority with regard to first-attempt intubation success rate. Trial Registration: ClinicalTrials.gov Identifier: NCT02000674.
RCT Entities:
Importance: Rocuronium and succinylcholine are often used for rapid sequence intubation, although the comparative efficacy of these paralytic agents for achieving successful intubation in an emergency setting has not been evaluated in clinical trials. Succinylcholine use has been associated with several adverse events not reported with rocuronium. Objective: To assess the noninferiority of rocuronium vs succinylcholine for tracheal intubation in out-of-hospital emergency situations. Design, Setting and Participants: Multicenter, single-blind, noninferiority randomized clinical trial comparing rocuronium (1.2 mg/kg) with succinylcholine (1 mg/kg) for rapid sequence intubation in 1248 adult patients needing out-of-hospital tracheal intubation. Enrollment occurred from January 2014 to August 2016 in 17 French out-of-hospital emergency medical units. The date of final follow-up was August 31, 2016. Interventions: Patients were randomly assigned to undergo tracheal intubation facilitated by rocuronium (n = 624) or succinylcholine (n = 624). Main Outcomes and Measures: The primary outcome was the intubation success rate on first attempt. A noninferiority margin of 7% was chosen. A per-protocol analysis was prespecified as the primary analysis. Results: Among 1248 patients who were randomized (mean age, 56 years; 501 [40.1%] women), 1230 (98.6%) completed the trial and 1226 (98.2%) were included in the per-protocol analysis. The number of patients with successful first-attempt intubation was 455 of 610 (74.6%) in the rocuronium group vs 489 of 616 (79.4%) in the succinylcholine group, with a between-group difference of -4.8% (1-sided 97.5% CI, -9% to ∞), which did not meet criteria for noninferiority. The most common intubation-related adverse events were hypoxemia (55 of 610 patients [9.0%]) and hypotension (39 of 610 patients [6.4%]) in the rocuronium group and hypoxemia (61 of 616 [9.9%]) and hypotension (62 of 616 patients [10.1%]) in the succinylcholine group. Conclusions and Relevance: Among patients undergoing endotracheal intubation in an out-of-hospital emergency setting, rocuronium, compared with succinylcholine, failed to demonstrate noninferiority with regard to first-attempt intubation success rate. Trial Registration: ClinicalTrials.gov Identifier: NCT02000674.
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