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肥胖患者中按理想体重与总体重给药罗库溴铵的前瞻性、观察性非劣效性研究。

Rocuronium Dosing by Ideal vs Total Body Weight in Obesity: A Prospective, Observational Non-inferiority Study.

机构信息

Department of Pharmacy, Advocate Christ Medical Center, Oak Lawn, Illinois.

Department of Pharmacy, Rush University Medical Center, Chicago, Illinois.

出版信息

West J Emerg Med. 2024 Jan;25(1):22-27. doi: 10.5811/westjem.60713.

Abstract

BACKGROUND

Providing adequate paralysis and appropriate sedation is challenging in patients with obesity during rapid sequence intubation (RSI). Pharmacokinetic parameters play an important role in dosing of rocuronium due to low lipophilicity. Rocuronium may be dosed based on ideal body weight (IBW). Current guidelines do not offer recommendations for dosing in the setting of obesity. Dosing depends on clinician preference based on total body weight (TBW) or IBW.

OBJECTIVE

In this study we performed non-inferiority analysis to compare the intubation conditions, duration of paralysis, and incidence of new-onset tachycardia or hypertension after intubation in obese patients requiring RSI in the emergency department (ED).

METHODS

This was a single-center, prospective, observational study. Eligible for enrollment were adult patients with a TBW ≥30% IBW or body mass index ≥30 kilograms per meters squared who presented to the ED requiring RSI with the use of rocuronium. Rocuronium was dosed according to intubating physicians' preference. Physicians completed a survey assessing intubation conditions. Height and weight used for the calculation of the dose, the dose of rocuronium, time of administration, and time of muscle function recovery were recorded. Endpoints assessed included grading of view during laryngoscopy, first-past success, and duration of paralysis.

RESULTS

In total, 96 patients were included, 54 in TBW and 42 in IBW. The TBW cohort received a mean of 1 milligram per kilogram (mg/kg) compared to 0.71 mg/kg in the IBW group. Excellent intubation conditions were observed in 68.5% in the TBW group and 73.8% in the IBW group. The non-inferiority analysis for relative risk of excellent intubation was 1.12 ( = 0.12, [90% CI 0.80-1.50]).

CONCLUSION

Non-inferiority analysis suggests that IBW dosing provides similar optimal intubation conditions when compared to TBW dosing, but the noninferiority comparison did not reach statistical significance. This study was unable to show statistical non-inferiority for IBW dosing.

摘要

背景

在肥胖患者进行快速序贯诱导(RSI)时,提供充分的麻痹和适当的镇静是一项挑战。由于亲脂性低,罗库溴铵的药代动力学参数在给药中起着重要作用。罗库溴铵可以根据理想体重(IBW)进行给药。目前的指南没有针对肥胖患者的给药建议。剂量取决于临床医生根据总体重(TBW)或 IBW 的偏好。

目的

在这项研究中,我们进行了非劣效性分析,以比较急诊科(ED)需要 RSI 的肥胖患者的插管条件、麻痹持续时间以及插管后新发心动过速或高血压的发生率。

方法

这是一项单中心、前瞻性、观察性研究。符合纳入标准的是体重指数(BMI)≥30 公斤/平方米或 TBW≥IBW30%的成年患者,这些患者因需要 RSI 而在 ED 就诊。罗库溴铵的剂量根据插管医生的偏好而定。医生完成了一项评估插管条件的调查。记录了用于计算剂量的身高和体重、罗库溴铵的剂量、给药时间和肌肉功能恢复时间。评估的终点包括喉镜检查时的视野分级、首次通过成功率和麻痹持续时间。

结果

共纳入 96 例患者,TBW 组 54 例,IBW 组 42 例。TBW 组平均接受 1 毫克/千克(mg/kg),而 IBW 组为 0.71mg/kg。TBW 组 68.5%和 IBW 组 73.8%的插管条件良好。相对风险的非劣效性分析显示,优秀插管的比值比为 1.12( = 0.12,[90% CI 0.80-1.50])。

结论

非劣效性分析表明,与 TBW 剂量相比,IBW 剂量提供了相似的最佳插管条件,但非劣效性比较没有达到统计学意义。本研究未能显示 IBW 剂量的统计学非劣效性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7add/10777192/c64bed6547df/wjem-25-22-g001.jpg

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