Effective bolus dose of remimazolam for i-gel® insertion in nonparalyzed patients: a dose-finding study.

IF 3.4 3区 医学 Q1 ANESTHESIOLOGY Canadian Journal of Anesthesia-Journal Canadien D Anesthesie Pub Date : 2024-09-01 Epub Date: 2024-04-26 DOI:10.1007/s12630-024-02762-w
Eunah Cho, Yun Ho Roh, Jisu Moon, Yangjin Kim, Seokyung Shin
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Abstract

Purpose: Remimazolam is a recently developed ultra-short-acting benzodiazepine used for anesthesia induction and maintenance. Nevertheless, the effective bolus dose of remimazolam for i-gel® (Intersurgical Ltd., Wokingham, Berkshire, UK) insertion without the use of neuromuscular blocking agents (NMBAs) has not been well established.

Methods: This study included 25 adult patients scheduled for surgery under general anesthesia who were eligible for i-gel use. Anesthesia was induced with predetermined bolus doses of remimazolam, starting at 0.3 mg·kg-1 for the first patient, without the use of NMBAs. All patients concurrently received remifentanil using target-controlled infusion (TCI) at a fixed effect-site concentration (Ce) of 3.0 ng·mL-1. Insertion of the i-gel was attempted 90 sec after remimazolam administration, and insertion conditions were assessed. Subsequent doses of remimazolam were decreased or increased by 0.05 mg·kg-1, depending on the success or failure of i-gel insertion.

Results: The mean (standard deviation) 50% effective dose (ED50) of a remimazolam bolus for successful i-gel insertion as determined by the modified Dixon's up-and-down method was 0.100 (0.027) mg·kg-1. The ED50 and ED95 estimated by isotonic regression were 0.111 (83% confidence interval [CI], 0.096 to 0.131) mg·kg-1 and 0.182 (95% CI, 0.144 to 0.195) mg·kg-1, respectively. None of the patients required treatment for hypotension or bradycardia during anesthesia induction.

Conclusion: Based on the ED95 of remimazolam bolus dose determined in our study, we recommend using 0.182 mg·kg-1 of remimazolam in combination with remifentanil TCI at a Ce of 3.0 ng·mL-1 for successful i-gel insertion without NMBAs in adult patients. This regimen seems effective with a low risk of hemodynamic instability during anesthesia induction.

Study registration: ClinicalTrials.gov ( NCT05298228 ); first submitted 6 March 2022.

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在非瘫痪病人体内插入 i-gel® 时瑞马唑仑的有效栓剂剂量:一项剂量探索研究。
目的:雷马唑仑是最近开发的一种超短效苯并二氮杂卓,用于麻醉诱导和维持。然而,在不使用神经肌肉阻滞剂(NMBA)的情况下,插入 i-gel®(Intersurgical Ltd., Wokingham, Berkshire, UK)时使用雷马唑仑的有效栓剂剂量尚未得到很好的确定:这项研究包括 25 名计划在全身麻醉下接受手术的成年患者,他们都符合使用 i-gel 的条件。在不使用 NMBAs 的情况下,用预定剂量的瑞马唑仑诱导麻醉,第一名患者的剂量从 0.3 mg-kg-1 开始。所有患者同时接受瑞芬太尼靶控输注(TCI),固定效应部位浓度(Ce)为 3.0 ng-mL-1。在注射雷马唑仑 90 秒后尝试插入 i-凝胶,并对插入条件进行评估。根据 i-gel 插入的成功或失败情况,将随后的雷马唑仑剂量减少或增加 0.05 毫克-千克-1:结果:根据改进的狄克逊上下法测定,成功插入 i-gel 的雷马唑仑栓剂 50%有效剂量(ED50)的平均值(标准偏差)为 0.100 (0.027) mg-kg-1。通过等渗回归估算出的 ED50 和 ED95 分别为 0.111(83% 置信区间 [CI],0.096 至 0.131)毫克-公斤-1 和 0.182(95% 置信区间 [CI],0.144 至 0.195)毫克-公斤-1。没有一名患者在麻醉诱导期间因低血压或心动过缓而需要治疗:结论:根据我们的研究确定的瑞马唑仑栓塞剂量 ED95,我们建议使用 0.182 mg-kg-1 的瑞马唑仑与 Ce 为 3.0 ng-mL-1 的瑞芬太尼 TCI 联用,以便在成人患者中成功插入 i-gel,而无需使用 NMBAs。这种方案似乎很有效,而且在麻醉诱导过程中出现血流动力学不稳定的风险较低:研究注册:ClinicalTrials.gov(NCT05298228);2022 年 3 月 6 日首次提交。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
8.50
自引率
7.10%
发文量
161
审稿时长
6-12 weeks
期刊介绍: The Canadian Journal of Anesthesia (the Journal) is owned by the Canadian Anesthesiologists’ Society and is published by Springer Science + Business Media, LLM (New York). From the first year of publication in 1954, the international exposure of the Journal has broadened considerably, with articles now received from over 50 countries. The Journal is published monthly, and has an impact Factor (mean journal citation frequency) of 2.127 (in 2012). Article types consist of invited editorials, reports of original investigations (clinical and basic sciences articles), case reports/case series, review articles, systematic reviews, accredited continuing professional development (CPD) modules, and Letters to the Editor. The editorial content, according to the mission statement, spans the fields of anesthesia, acute and chronic pain, perioperative medicine and critical care. In addition, the Journal publishes practice guidelines and standards articles relevant to clinicians. Articles are published either in English or in French, according to the language of submission.
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