Effect of Remifentanil vs Neuromuscular ...
Type de document :
Article dans une revue scientifique: Article original
DOI :
PMID :
URL permanente :
Titre :
Effect of Remifentanil vs Neuromuscular Blockers During Rapid Sequence Intubation on Successful Intubation Without Major Complications Among Patients at Risk of Aspiration: A Randomized Clinical Trial
Auteur(s) :
Grillot, Nicolas [Auteur]
Centre d'investigation clinique (CIC) de Nantes -CIC Plurithématique [CIC 0004 - Nantes]
Lebuffe, Gilles [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - ULR 7365
Huet, Olivier [Auteur]
CHRU Brest - Département d'Anesthésie Réanimation [CHU - BREST - DAR]
Lasocki, Sigismond [Auteur]
Centre Hospitalier Universitaire d'Angers [CHU Angers]
Pichon, Xavier [Auteur]
Centre Hospitalier Universitaire de Toulouse [CHU Toulouse]
Oudot, Mathieu [Auteur]
Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon [CHD Vendée]
Bruneau, Nathalie [Auteur]
Centre Hospitalier Régional Universitaire [CHU Lille] [CHRU Lille]
David, Jean-Stéphane [Auteur]
Research on Healthcare Performance [RESHAPE - Inserm U1290 - UCBL1]
Bouzat, Pierre [Auteur]
Grenoble Institut des Neurosciences [GIN]
Jobert, Alexandra [Auteur]
Centre Hospitalier Universitaire de Nantes = Nantes University Hospital [CHU Nantes]
MethodS in Patients-centered outcomes and HEalth ResEarch [SPHERE]
Tching-Sin, Martine [Auteur]
Centre Hospitalier Universitaire de Nantes = Nantes University Hospital [CHU Nantes]
Feuillet, Fanny [Auteur]
Centre Hospitalier Universitaire de Nantes = Nantes University Hospital [CHU Nantes]
MethodS in Patients-centered outcomes and HEalth ResEarch [SPHERE]
Cinotti, Raphael [Auteur]
Centre d'investigation clinique (CIC) de Nantes -CIC Plurithématique [CIC 0004 - Nantes]
Asehnoune, Karim [Auteur]
Centre d'investigation clinique (CIC) de Nantes -CIC Plurithématique [CIC 0004 - Nantes]
Roquilly, Antoine [Auteur]
Centre d'investigation clinique (CIC) de Nantes -CIC Plurithématique [CIC 0004 - Nantes]
Centre d'investigation clinique (CIC) de Nantes -CIC Plurithématique [CIC 0004 - Nantes]
Lebuffe, Gilles [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - ULR 7365
Huet, Olivier [Auteur]
CHRU Brest - Département d'Anesthésie Réanimation [CHU - BREST - DAR]
Lasocki, Sigismond [Auteur]
Centre Hospitalier Universitaire d'Angers [CHU Angers]
Pichon, Xavier [Auteur]
Centre Hospitalier Universitaire de Toulouse [CHU Toulouse]
Oudot, Mathieu [Auteur]
Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon [CHD Vendée]
Bruneau, Nathalie [Auteur]
Centre Hospitalier Régional Universitaire [CHU Lille] [CHRU Lille]
David, Jean-Stéphane [Auteur]
Research on Healthcare Performance [RESHAPE - Inserm U1290 - UCBL1]
Bouzat, Pierre [Auteur]
Grenoble Institut des Neurosciences [GIN]
Jobert, Alexandra [Auteur]
Centre Hospitalier Universitaire de Nantes = Nantes University Hospital [CHU Nantes]
MethodS in Patients-centered outcomes and HEalth ResEarch [SPHERE]
Tching-Sin, Martine [Auteur]
Centre Hospitalier Universitaire de Nantes = Nantes University Hospital [CHU Nantes]
Feuillet, Fanny [Auteur]
Centre Hospitalier Universitaire de Nantes = Nantes University Hospital [CHU Nantes]
MethodS in Patients-centered outcomes and HEalth ResEarch [SPHERE]
Cinotti, Raphael [Auteur]
Centre d'investigation clinique (CIC) de Nantes -CIC Plurithématique [CIC 0004 - Nantes]
Asehnoune, Karim [Auteur]
Centre d'investigation clinique (CIC) de Nantes -CIC Plurithématique [CIC 0004 - Nantes]
Roquilly, Antoine [Auteur]
Centre d'investigation clinique (CIC) de Nantes -CIC Plurithématique [CIC 0004 - Nantes]
Titre de la revue :
Journal of the American Medical Association
Nom court de la revue :
JAMA
Numéro :
329
Pagination :
28-38
Éditeur :
American Medical Association (AMA)
Date de publication :
2023-01-03
ISSN :
1538-3598
Discipline(s) HAL :
Sciences du Vivant [q-bio]
Résumé en anglais : [en]
Importance It is uncertain whether a rapid-onset opioid is noninferior to a rapid-onset neuromuscular blocker during rapid sequence intubation when used in conjunction with a hypnotic agent.
Objective To determine ...
Lire la suite >Importance It is uncertain whether a rapid-onset opioid is noninferior to a rapid-onset neuromuscular blocker during rapid sequence intubation when used in conjunction with a hypnotic agent. Objective To determine whether remifentanil is noninferior to rapid-onset neuromuscular blockers for rapid sequence intubation. Design, Setting, and Participants Multicenter, randomized, open-label, noninferiority trial among 1150 adults at risk of aspiration (fasting for <6 hours, bowel occlusion, recent trauma, or severe gastroesophageal reflux) who underwent tracheal intubation in the operating room at 15 hospitals in France from October 2019 to April 2021. Follow-up was completed on May 15, 2021. Interventions Patients were randomized to receive neuromuscular blockers (1 mg/kg of succinylcholine or rocuronium; n = 575) or remifentanil (3 to 4 μg/kg; n = 575) immediately after injection of a hypnotic. Main Outcomes and Measures The primary outcome was assessed in all randomized patients (as-randomized population) and in all eligible patients who received assigned treatment (per-protocol population). The primary outcome was successful tracheal intubation on the first attempt without major complications, defined as lung aspiration of digestive content, oxygen desaturation, major hemodynamic instability, sustained arrhythmia, cardiac arrest, and severe anaphylactic reaction. The prespecified noninferiority margin was 7.0%. Results Among 1150 randomized patients (mean age, 50.7 [SD, 17.4] years; 573 [50%] women), 1130 (98.3%) completed the trial. In the as-randomized population, tracheal intubation on the first attempt without major complications occurred in 374 of 575 patients (66.1%) in the remifentanil group and 408 of 575 (71.6%) in the neuromuscular blocker group (between-group difference adjusted for randomization strata and center, –6.1%; 95% CI, –11.6% to –0.5%; P = .37 for noninferiority), demonstrating inferiority. In the per-protocol population, 374 of 565 patients (66.2%) in the remifentanil group and 403 of 565 (71.3%) in the neuromuscular blocker group had successful intubation without major complications (adjusted difference, –5.7%; 2-sided 95% CI, –11.3% to –0.1%; P = .32 for noninferiority). An adverse event of hemodynamic instability was recorded in 19 of 575 patients (3.3%) with remifentanil and 3 of 575 (0.5%) with neuromuscular blockers (adjusted difference, 2.8%; 95% CI, 1.2%-4.4%). Conclusions and Relevance Among adults at risk of aspiration during rapid sequence intubation in the operating room, remifentanil, compared with neuromuscular blockers, did not meet the criterion for noninferiority with regard to successful intubation on first attempt without major complications. Although remifentanil was statistically inferior to neuromuscular blockers, the wide confidence interval around the effect estimate remains compatible with noninferiority and limits conclusions about the clinical relevance of the difference. Trial Registration ClinicalTrials.gov Identifier: NCT03960801Lire moins >
Lire la suite >Importance It is uncertain whether a rapid-onset opioid is noninferior to a rapid-onset neuromuscular blocker during rapid sequence intubation when used in conjunction with a hypnotic agent. Objective To determine whether remifentanil is noninferior to rapid-onset neuromuscular blockers for rapid sequence intubation. Design, Setting, and Participants Multicenter, randomized, open-label, noninferiority trial among 1150 adults at risk of aspiration (fasting for <6 hours, bowel occlusion, recent trauma, or severe gastroesophageal reflux) who underwent tracheal intubation in the operating room at 15 hospitals in France from October 2019 to April 2021. Follow-up was completed on May 15, 2021. Interventions Patients were randomized to receive neuromuscular blockers (1 mg/kg of succinylcholine or rocuronium; n = 575) or remifentanil (3 to 4 μg/kg; n = 575) immediately after injection of a hypnotic. Main Outcomes and Measures The primary outcome was assessed in all randomized patients (as-randomized population) and in all eligible patients who received assigned treatment (per-protocol population). The primary outcome was successful tracheal intubation on the first attempt without major complications, defined as lung aspiration of digestive content, oxygen desaturation, major hemodynamic instability, sustained arrhythmia, cardiac arrest, and severe anaphylactic reaction. The prespecified noninferiority margin was 7.0%. Results Among 1150 randomized patients (mean age, 50.7 [SD, 17.4] years; 573 [50%] women), 1130 (98.3%) completed the trial. In the as-randomized population, tracheal intubation on the first attempt without major complications occurred in 374 of 575 patients (66.1%) in the remifentanil group and 408 of 575 (71.6%) in the neuromuscular blocker group (between-group difference adjusted for randomization strata and center, –6.1%; 95% CI, –11.6% to –0.5%; P = .37 for noninferiority), demonstrating inferiority. In the per-protocol population, 374 of 565 patients (66.2%) in the remifentanil group and 403 of 565 (71.3%) in the neuromuscular blocker group had successful intubation without major complications (adjusted difference, –5.7%; 2-sided 95% CI, –11.3% to –0.1%; P = .32 for noninferiority). An adverse event of hemodynamic instability was recorded in 19 of 575 patients (3.3%) with remifentanil and 3 of 575 (0.5%) with neuromuscular blockers (adjusted difference, 2.8%; 95% CI, 1.2%-4.4%). Conclusions and Relevance Among adults at risk of aspiration during rapid sequence intubation in the operating room, remifentanil, compared with neuromuscular blockers, did not meet the criterion for noninferiority with regard to successful intubation on first attempt without major complications. Although remifentanil was statistically inferior to neuromuscular blockers, the wide confidence interval around the effect estimate remains compatible with noninferiority and limits conclusions about the clinical relevance of the difference. Trial Registration ClinicalTrials.gov Identifier: NCT03960801Lire moins >
Langue :
Anglais
Audience :
Internationale
Vulgarisation :
Non
Établissement(s) :
Université de Lille
CHU Lille
CHU Lille
Collections :
Équipe(s) de recherche :
Modélisation biopharmaceutique et pharmacocinétique
Date de dépôt :
2023-05-25T02:19:39Z
2023-10-03T07:43:01Z
2023-10-03T07:43:01Z