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瑞马唑仑靶控输注时按效应室浓度预测呼吸抑制的程度:一项随机对照试验。

The degree of respiratory depression according to the effect-site concentration in remimazolam target-controlled infusion: A randomised controlled trial.

机构信息

From the Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, Suwon, South Korea (SJP, SKM, GC, JEK, HYK).

出版信息

Eur J Anaesthesiol. 2024 Oct 1;41(10):728-737. doi: 10.1097/EJA.0000000000002045. Epub 2024 Jul 29.

DOI:10.1097/EJA.0000000000002045
PMID:39076003
Abstract

BACKGROUND

Remimazolam is not only associated with a lower incidence of respiratory depression than propofol but also in itself has the risk of respiratory depression.

OBJECTIVE

We investigated respiratory depression following remimazolam infusion, targeting different effect-site concentrations using target-controlled infusion.

DESIGN

A prospective, double-blind, randomised controlled study.

SETTING

Tertiary hospital, Suwon, South Korea, from April 2022 to November 2022.

PARTICIPANTS

One hundred and seven patients scheduled for general anaesthesia were randomised into three groups targeting remimazolam effect-site concentrations of 500 (RMZ-500) ( n  = 36), 1000 (RMZ-1000) ( n  = 35) and 1500 ng ml -1 (RMZ-1500) ( n  = 36).

INTERVENTIONS

Remimazolam was solely infused for 10 min according to target effect-site concentrations. According to the degree of SpO 2 decrease, oxygen desaturations were managed with the following respiratory supports: jaw-thrust for SpO 2 less than 97%, 100% oxygen delivery for SpO 2 less than 93% and assisted ventilation for SpO 2 less than 90%.

MAIN OUTCOME MEASURES

The incidence of each respiratory support, along with respiratory variables (at baseline, 5 min and 10 min after remimazolam infusion) and loss of consciousness were observed for 10 min after remimazolam target-controlled infusion.

RESULTS

Both RMZ-1000 and RMZ-1500 required more frequent respiratory support than RMZ-500 (both P  < 0.001), with nearly identical frequencies between RMZ-1000 and RMZ-1500. In terms of respiratory support, the incidence of assisted ventilation was significantly lower in RMZ-500 (2.8%) than RMZ-1000 (48.6%) and RMZ-1500 (50%) ( P  < 0.001). RMZ-1000 and RMZ-1500 achieved loss of consciousness in all patients; RMZ-500 only achieved loss of consciousness in 86.1% of patients ( P  = 0.010). In patients who maintained spontaneous respiration, tidal volume decreased by 41 to 48% and respiratory rate increased by 118 to 158% at 5 and 10 min, significantly compared to baseline in all groups ( P  < 0.001).

CONCLUSIONS

Remimazolam infusion, like that of other benzodiazepines, led to respiratory depression, which was more prominent at higher target effect-site concentrations. Therefore, appropriate countermeasures should be developed to prevent oxygen desaturation.

TRIAL REGISTRATION

CRIS ( https://cris.nih.go.kr ), identifier: KCT0006952.

摘要

背景

雷米唑仑不仅比丙泊酚更不易引起呼吸抑制,而且其本身也有呼吸抑制的风险。

目的

我们通过使用靶控输注,针对不同的效应室浓度,研究雷米唑仑输注后的呼吸抑制情况。

设计

前瞻性、双盲、随机对照研究。

地点

韩国水原市的一家三级医院,于 2022 年 4 月至 2022 年 11 月进行。

参与者

107 名计划接受全身麻醉的患者被随机分为三组,目标效应室浓度分别为 500ng/ml(RMZ-500)(n=36)、1000ng/ml(RMZ-1000)(n=35)和 1500ng/ml(RMZ-1500)(n=36)。

干预措施

根据目标效应室浓度,雷米唑仑单独输注 10 分钟。根据 SpO 2 下降程度,通过以下呼吸支持来管理氧饱和度降低:对于 SpO 2 低于 97%的患者,进行下颌推挤;对于 SpO 2 低于 93%的患者,给予 100%氧气输送;对于 SpO 2 低于 90%的患者,给予辅助通气。

主要观察指标

观察雷米唑仑靶控输注后 10 分钟内的每一种呼吸支持的发生情况,以及呼吸变量(在雷米唑仑输注前、输注后 5 分钟和 10 分钟)和意识丧失情况。

结果

RMZ-1000 和 RMZ-1500 组比 RMZ-500 组需要更频繁的呼吸支持(均 P < 0.001),RMZ-1000 组和 RMZ-1500 组之间的频率几乎相同。在呼吸支持方面,RMZ-500 组的辅助通气发生率明显低于 RMZ-1000 组(48.6%)和 RMZ-1500 组(50%)(P < 0.001)。RMZ-1000 和 RMZ-1500 组所有患者均出现意识丧失;RMZ-500 组仅 86.1%的患者出现意识丧失(P = 0.010)。在维持自主呼吸的患者中,潮气量在 5 分钟和 10 分钟时分别下降 41%至 48%,呼吸频率增加 118%至 158%,与所有组的基线值相比均有显著差异(均 P < 0.001)。

结论

雷米唑仑输注与其他苯二氮䓬类药物一样,会导致呼吸抑制,在更高的靶效应室浓度下更为明显。因此,应制定适当的对策来预防氧饱和度降低。

试验注册

CRIS(https://cris.nih.go.kr),标识符:KCT0006952。

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