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The optimal exhaled concentration of sevoflurane for intubation without neuromuscular blockade using clinical bolus doses of remifentanil: A randomized controlled trial.

ABSTRACT: The aim of this study was to investigate the optimal exhaled sevoflurane concentration that produces adequate endotracheal intubation conditions when sevoflurane is combined with the different bolus doses of remifentanil used in clinical practice.The patients were randomized to 3 groups (groups 1.0, 1.5, and 2.0), receiving remifentanil bolus doses of 1.0, 1.5, and 2.0??g/kg, respectively. For each group, the concentration of sevoflurane used for each consecutive patient was increased or decreased using the "up-and-down" method based on the success or failure to achieve adequate conditions for intubation in the previous patient. The remifentanil bolus dose was administered 90 s before intubation and after the target sevoflurane concentration was achieved.In groups 1.0, 1.5, and 2.0, the effective concentration in 50% (EC50) of the sevoflurane concentration required to perform successful intubation was 3.0, 2.0, and 1.29 vol% and the effective concentration in 95% was 3.45, 2.91, and 1.89 vol%, respectively. When sevoflurane was administered for the induction, the increase in heart rate (HR) of group 1.0 was the highest among the groups. The highest number of adverse events occurred in group 2.0, including vocal cord rigidity, hypotension, and bradycardia.The EC50 of the sevoflurane concentration was 3.0, 2.0, and 1.29 vol% when it was combined with a bolus dose of remifentanil of 1.0, 1.5, and 2.0??g/kg, respectively. Of the 3 different bolus doses of remifentanil, the dose of 1.5??g/kg was least associated with changes in the HR/mean blood pressure during intubation without increasing adverse effects.

SUBMITTER: Goo EK

PROVIDER: S-EPMC5340460 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature

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The optimal exhaled concentration of sevoflurane for intubation without neuromuscular blockade using clinical bolus doses of remifentanil: A randomized controlled trial.

Goo Eui-Kyoung EK Lee Jong Seok JS Koh Jae Chul JC

Medicine 20170301 9

<h4>Background</h4>The aim of this study was to investigate the optimal exhaled sevoflurane concentration that produces adequate endotracheal intubation conditions when sevoflurane is combined with the different bolus doses of remifentanil used in clinical practice.<h4>Methods</h4>The patients were randomized to 3 groups (groups 1.0, 1.5, and 2.0), receiving remifentanil bolus doses of 1.0, 1.5, and 2.0 μg/kg, respectively. For each group, the concentration of sevoflurane used for each consecuti ...[more]

PMID: 28248887

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Project description:ImportanceIt 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.ObjectiveTo determine whether remifentanil is noninferior to rapid-onset neuromuscular blockers for rapid sequence intubation.Design, setting, and participantsMulticenter, 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.InterventionsPatients 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 measuresThe 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%.ResultsAmong 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 relevanceAmong 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 registrationClinicalTrials.gov Identifier: NCT03960801.

Dataset Information

The optimal exhaled concentration of sevoflurane for intubation without neuromuscular blockade using clinical bolus doses of remifentanil: A randomized controlled trial.

Publications

The optimal exhaled concentration of sevoflurane for intubation without neuromuscular blockade using clinical bolus doses of remifentanil: A randomized controlled trial.

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