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单次推注剂量与持续输注瑞马唑仑用于非心脏手术全身麻醉诱导的比较:一项单中心前瞻性随机对照试验。

Comparison between single bolus dose administration and continuous infusion of remimazolam for general anesthesia induction in non-cardiac surgery: a single-center prospective randomized controlled trial.

作者信息

Ikeda Tsuyoshi, Miyoshi Hirotsugu, Kido Kenshiro, Sumii Ayako, Otsuki Sachiko, Kato Takahiro, Nakamura Ryuji, Narasaki Soshi, Tsutsumi Yasuo M

机构信息

Department of Anesthesiology and Critical Care, Hiroshima University, Hiroshima, Japan.

Department of Anesthesiology and Critical Care Institution, Hiroshima University, 1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, Japan.

出版信息

BMC Anesthesiol. 2025 Apr 2;25(1):150. doi: 10.1186/s12871-025-03032-y.

Abstract

BACKGROUND

Remimazolam is a short-acting benzodiazepine anesthetic recommended for continuous infusion during anesthesia induction. However, the safety and efficacy of single bolus dose administration remain under investigation. This study compared continuous infusion with single bolus dose administration and assessed the safety of a single bolus dose administration.

METHODS

The participants were randomly assigned into three groups based on the method of remimazolam administration the day before surgery: (1) continuous infusion group (continuous infusion at 12 mg/kg/h), (2) single bolus dose administration of 0.1 group (single administration of 0.1 mg/kg), or (3) single bolus dose administration of 0.2 group (single administration of 0.2 mg/kg). The time between drug administration and loss of consciousness was determined, and hemodynamic monitoring was performed.

RESULTS

67 patients (continuous infusion group (n = 22), single bolus dose administration of 0.1 group (n = 22), and single bolus dose administration of 0.2 group (n = 23)) were included in the study. The different times to loss of consciousness were 88.2 ± 16.2 s, 59.5 ± 31.5 s, and 42.6 ± 11.4 s in the continuous infusion group, single bolus dose administration of 0.1 group, and single bolus dose administration of 0.2 group, respectively. No significant differences were observed in the incidence of adverse events between the groups. The results are presented as mean ± standard deviation (SD).

CONCLUSIONS

Single-dose remimazolam is a safe method for anesthesia induction, resulting in shorter time to loss of consciousness compared with continuous infusion, while maintaining a similar incidence of adverse events.

TRIAL REGISTRATION

jRCTs061230049, registered on 17/08/2023.

摘要

背景

瑞米唑仑是一种短效苯二氮䓬类麻醉剂,推荐在麻醉诱导期间持续输注。然而,单次推注给药的安全性和有效性仍在研究中。本研究比较了持续输注与单次推注给药,并评估了单次推注给药的安全性。

方法

根据手术前一天瑞米唑仑的给药方法,将参与者随机分为三组:(1)持续输注组(以12mg/kg/h持续输注),(2)0.1mg/kg单次推注给药组(单次给予0.1mg/kg),或(3)0.2mg/kg单次推注给药组(单次给予0.2mg/kg)。确定给药至意识消失的时间,并进行血流动力学监测。

结果

67例患者(持续输注组(n = 22)、0.1mg/kg单次推注给药组(n = 22)和0.2mg/kg单次推注给药组(n = 23))纳入研究。持续输注组、0.1mg/kg单次推注给药组和0.2mg/kg单次推注给药组意识消失的不同时间分别为88.2±16.2秒、59.5±31.5秒和42.6±11.4秒。各组间不良事件发生率未观察到显著差异。结果以平均值±标准差(SD)表示。

结论

单剂量瑞米唑仑是一种安全的麻醉诱导方法,与持续输注相比,意识消失时间更短,同时不良事件发生率相似。

试验注册

jRCTs061230049,于2023年8月17日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7d26/11963264/d49a4939e4f8/12871_2025_3032_Fig1_HTML.jpg

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