Effect of Rocuronium vs Succinylcholine on Endotracheal Intubation Success Rate Among Patients Undergoing Out-of-Hospital Rapid Sequence Intubation: A Randomized Clinical Trial.


Journal

JAMA
ISSN: 1538-3598
Titre abrégé: JAMA
Pays: United States
ID NLM: 7501160

Informations de publication

Date de publication:
17 12 2019
Historique:
entrez: 18 12 2019
pubmed: 18 12 2019
medline: 1 1 2020
Statut: ppublish

Résumé

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. To assess the noninferiority of rocuronium vs succinylcholine for tracheal intubation in out-of-hospital emergency situations. 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. Patients were randomly assigned to undergo tracheal intubation facilitated by rocuronium (n = 624) or succinylcholine (n = 624). 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. 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. 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. ClinicalTrials.gov Identifier: NCT02000674.

Identifiants

pubmed: 31846014
pii: 2757578
doi: 10.1001/jama.2019.18254
pmc: PMC6990819
doi:

Substances chimiques

Succinylcholine J2R869A8YF
Rocuronium WRE554RFEZ

Banques de données

ClinicalTrials.gov
['NCT02000674']

Types de publication

Comparative Study Equivalence Trial Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

2303-2312

Commentaires et corrections

Type : CommentIn
Type : CommentIn
Type : CommentIn

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Auteurs

Bertrand Guihard (B)

Department of Emergency, CHU de la Réunion, Allée des Topazes, Saint Denis, Réunion, France.

Charlotte Chollet-Xémard (C)

Groupe Hospitalo-Universitaire Henri Mondor, SAMU 94, Assistance Publique-Hôpitaux de Paris, Créteil, France.

Philippe Lakhnati (P)

SMUR 95, Centre Hospitalier de Gonesse, Gonesse, France.

Benoit Vivien (B)

Department of Anesthesia & Critical Care - SAMU, Assistance Publique - Hôpitaux de Paris, Hôpital Necker-Enfants Malades, Université Paris Descartes, Paris, France.

Claire Broche (C)

Département d'Anesthésie-Réanimation-SMUR, Hôpital Universitaire Lariboisière, AP-HP, Paris, France.

Dominique Savary (D)

Emergency Department, General Hospital of Annecy, Annecy, France.

Agnes Ricard-Hibon (A)

SMUR de l'hôpital Beaujon, Clichy, France.

Pierre-Jean Marianne Dit Cassou (PJ)

Department of Emergency, CHU de la Réunion, Réunion, France.

Frédéric Adnet (F)

AP-HP, Urgences-SAMU 93, Unité Recherche-Enseignement-Qualité, Hôpital Avicenne, Bobigny, France.

Eric Wiel (E)

Univ Lille, EA 2694 - Santé Publique: Epidémiologie et Qualité des Soins, Lille, France.
French National Out-of-Hospital Cardiac Arrest Registry Research Group - Registre électronique des Arrêts Cardiaques, Lille, France.
Emergency Medicine Department and SAMU 59, Lille University Hospital, Lille, France.

Juliette Deutsch (J)

Department of Emergency Medicine, Groupe Hospitalier Broca Cochin Hôtel-Dieu, Paris, France.

Cindy Tissier (C)

Department of Emergency Medicine, University Hospital Dijon, Dijon, France.

Thomas Loeb (T)

Raymond Poincaré Hospital (APHP), SAMU 92, Paris, France.

Vincent Bounes (V)

Pôle Médecine d'Urgence, Hôpital Universitaire de Purpan, Toulouse, France.
INSERM UMR 1027, Université Paul Sabatier, Toulouse, France.

Emmanuel Rousseau (E)

Services de Médecine d'Urgence et de Réanimation, Pôle Urgence Réanimation, SAMU 77, Melun, France.

Patricia Jabre (P)

AP-HP, Service d'Aide Médicale d'Urgence (SAMU) de Paris and Paris Sudden Death Expertise Center, Université Paris Descartes, Paris, France.

Laetitia Huiart (L)

INSERM CIC 1410 Clinical and Epidemiology/ CHU Réunion/Université de la Réunion, Saint-Pierre, Reunion, France.
Department of Population Health, Luxembourg Institute of Health, Strassen, Luxembourg.

Cyril Ferdynus (C)

Departement d'Informatique Clinique, Centre Hospitalier Universitaire de La Réunion Site Félix Guyon, Saint-Denis, France.

Xavier Combes (X)

Department of Emergency, CHU de la Réunion, Université de la Réunion, Réunion, France.

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