{
    "abstract": "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.\nTo determine whether remifentanil is noninferior to rapid-onset neuromuscular blockers for rapid sequence intubation.\nMulticenter, 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.\nPatients were randomized to receive neuromuscular blockers (1 mg/kg of succinylcholine or rocuronium; n\u2009=\u2009575) or remifentanil (3 to 4 \u03bcg/kg; n\u2009=\u2009575) immediately after injection of a hypnotic.\nThe 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%.\nAmong 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\u2009=\u2009.37 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\u2009=\u2009.32 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%).\nAmong 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.\nClinicalTrials.gov Identifier: NCT03960801.",
    "authors": [
        {
            "affiliation": "Nantes Universit\u00e9, CHU Nantes, Service d'Anesth\u00e9sie R\u00e9animation Chirurgicale, INSERM CIC 0004 Immunologie et Infectiologie, Nantes, France.",
            "firstname": "Nicolas",
            "initials": "N",
            "lastname": "Grillot"
        },
        {
            "affiliation": "Universit\u00e9 Lille, CHU Lille, ULR 7354-GRITA Groupe de Recherche sur les Formes Injectables et les Technologies Associ\u00e9es, P\u00f4le Anesth\u00e9sie R\u00e9animation, Lille, France.",
            "firstname": "Gilles",
            "initials": "G",
            "lastname": "Lebuffe"
        },
        {
            "affiliation": "D\u00e9partement d'Anesth\u00e9sie R\u00e9animation et M\u00e9decine P\u00e9ri-op\u00e9ratoire, CHRU Brest, Universit\u00e9 de Bretagne occidentale, Brest, France.",
            "firstname": "Olivier",
            "initials": "O",
            "lastname": "Huet"
        },
        {
            "affiliation": "Department of Anesthesiology and Critical Care Medicine, University Hospital of Angers, Angers, France.",
            "firstname": "Sigismond",
            "initials": "S",
            "lastname": "Lasocki"
        },
        {
            "affiliation": "Department of Anesthesiology and Critical Care Medicine, University Hospital of Toulouse, University Toulouse III-Paul-Sabatier, Toulouse, France.",
            "firstname": "Xavier",
            "initials": "X",
            "lastname": "Pichon"
        },
        {
            "affiliation": "Department of Anesthesiology, Centre Hospitalier Departemental, La Roche sur Yon, France.",
            "firstname": "Mathieu",
            "initials": "M",
            "lastname": "Oudot"
        },
        {
            "affiliation": "Universit\u00e9 Lille, CHU Lille, Hopital Salengro, P\u00f4le Anesth\u00e9sie R\u00e9animation, Lille, France.",
            "firstname": "Nathalie",
            "initials": "N",
            "lastname": "Bruneau"
        },
        {
            "affiliation": "Service d'Anesth\u00e9sie R\u00e9animation, Groupe Hospitalier Sud, Hospices Civils de Lyon, Research on Healthcare Performance (RESHAPE), INSERM U1290, University Claude Bernard Lyon 1, Lyon, France.",
            "firstname": "Jean-St\u00e9phane",
            "initials": "JS",
            "lastname": "David"
        },
        {
            "affiliation": "Universit\u00e9 Grenoble Alpes, Inserm, U1216, CHU Grenoble Alpes, Grenoble Institut Neurosciences, Grenoble, France.",
            "firstname": "Pierre",
            "initials": "P",
            "lastname": "Bouzat"
        },
        {
            "affiliation": "Nantes Universit\u00e9, CHU Nantes, DRCI, Departement Promotion, Nantes, France.\nNantes Universit\u00e9, Univerisit\u00e9 Tours, CHU Nantes, CHU Tours, INSERM, Methods in Patient-Centered Outcomes and Health Research, SPHERE, Nantes, France.",
            "firstname": "Alexandra",
            "initials": "A",
            "lastname": "Jobert"
        },
        {
            "affiliation": "Nantes Universit\u00e9, CHU Nantes, Service de Pharmacie, H\u00f4tel Dieu, Nantes, France.",
            "firstname": "Martine",
            "initials": "M",
            "lastname": "Tching-Sin"
        },
        {
            "affiliation": "Nantes Universit\u00e9, Univerisit\u00e9 Tours, CHU Nantes, CHU Tours, INSERM, Methods in Patient-Centered Outcomes and Health Research, SPHERE, Nantes, France.\nNantes Universit\u00e9, CHU Nantes, Service de Pharmacie, H\u00f4tel Dieu, Nantes, France.\nNantes Universit\u00e9, CHU Nantes, DRI, Plateforme de M\u00e9thodologie et de Biostatistique, Nantes, France.",
            "firstname": "Fanny",
            "initials": "F",
            "lastname": "Feuillet"
        },
        {
            "affiliation": "Nantes Universit\u00e9, CHU Nantes, Service d'Anesth\u00e9sie R\u00e9animation Chirurgicale, INSERM CIC 0004 Immunologie et Infectiologie, Nantes, France.",
            "firstname": "Raphael",
            "initials": "R",
            "lastname": "Cinotti"
        },
        {
            "affiliation": "Nantes Universit\u00e9, CHU Nantes, Service d'Anesth\u00e9sie R\u00e9animation Chirurgicale, INSERM CIC 0004 Immunologie et Infectiologie, Nantes, France.",
            "firstname": "Karim",
            "initials": "K",
            "lastname": "Asehnoune"
        },
        {
            "affiliation": "Nantes Universit\u00e9, CHU Nantes, Service d'Anesth\u00e9sie R\u00e9animation Chirurgicale, INSERM CIC 0004 Immunologie et Infectiologie, Nantes, France.",
            "firstname": "Antoine",
            "initials": "A",
            "lastname": "Roquilly"
        },
        {
            "affiliation": null,
            "firstname": null,
            "initials": null,
            "lastname": null
        }
    ],
    "conclusions": null,
    "copyrights": null,
    "doi": "10.1001/jama.2022.23550\n10.1136/qshc.2005.016964\n10.1016/j.accpm.2018.03.013\n10.1097/ALN.0000000000004002\n10.1001/jama.2021.1727\n10.1097/ALN.0000000000003791\n10.4103/0019-5049.179463\n10.1186/s12245-021-00368-3\n10.1007/s00268-016-3712-x\n10.1111/all.13456\n10.1345/aph.1P753\n10.1097/00000542-200601000-00022\n10.1016/S2213-2600(18)30294-7\n10.1016/j.bja.2017.11.106\n10.1016/j.jclinane.2009.12.004\n10.1097/00003643-200301000-00007\n10.1001/jama.2013.281053\n10.1186/s13063-021-05192-x\n10.1213/00000539-200108000-00050\n10.1016/j.jclinane.2005.07.002\n10.1001/jama.2016.20603\n10.1111/anae.15626\n10.1016/j.annfar.2009.01.020\n10.1001/jama.2019.18254\n10.1016/j.accpm.2020.01.005\n10.1001/jama.2018.6496\n10.1001/jamasurg.2018.3577\n10.1056/NEJMoa1812405\n10.1007/s00134-015-3796-z\n10.1164/rccm.201210-1851OC\n10.1001/jama.2021.22002\n10.1001/jama.2012.87802\n10.1056/NEJMra1510063\n10.1016/j.accpm.2019.09.010\n10.1007/s00101-020-00739-0\n10.1097/00000542-199604000-00009\n10.1046/j.1365-2044.1999.01070.x\n10.1016/S0140-6736(20)32532-0\n10.1007/s00134-009-1717-8\n10.1111/1742-6723.12704",
    "journal": "JAMA",
    "keywords": [],
    "methods": null,
    "publication_date": "2023-01-04",
    "pubmed_id": "36594947\n17913779\n29802903\n34762729\n33755076\n33848324\n27141109\n34404352\n27646281\n29654608\n21427295\n16394702\n30224322\n29793603\n20868965\n12557834\n24141714\n33785069\n11473886\n16563326\n28118659\n34855986\n19304443\n31846014\n31926308\n29800096\n30347104\n30779528\n25869405\n23348979\n34879143\n23268518\n28976859\n31614244\n32112114\n8638836\n10540090\n33308472\n19921148\n27785883",
    "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\u2009=\u2009.37 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\u2009=\u2009.32 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%).",
    "title": "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.",
    "xml": "<Element 'PubmedArticle' at 0x7885044ce4d0>"
}