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瑞马唑仑与丙泊酚用于全身麻醉下术后谵妄的比较:一项随机对照试验的系统评价和荟萃分析

Postoperative delirium under general anaesthesia by remimazolam versus propofol: A systematic review and meta-analysis of randomised controlled trials.

作者信息

Suga Masafumi, Yasuhara Jun, Watanabe Atsuyuki, Takagi Hisato, Kuno Toshiki, Nishimura Takeshi, Ijuin Shinichi, Taira Takuya, Inoue Akihiko, Ishihara Satoshi, Pakavakis Adrian, Glassford Neil, Shehabi Yahya

机构信息

Department of Intensive Care, Monash Medical Centre, Melbourne, Australia; Department of Emergency and Critical Care Medicine, Hyogo Emergency Medical Centre, Hyogo, Japan.

Department of Pediatric Cardiology, Monash Heart and Monash Children's Hospital, Monash Health, Melbourne, Australia.

出版信息

J Clin Anesth. 2025 Feb;101:111735. doi: 10.1016/j.jclinane.2024.111735. Epub 2024 Dec 30.

DOI:10.1016/j.jclinane.2024.111735
PMID:39832842
Abstract

BACKGROUND

Remimazolam, an ultra-short-acting benzodiazepine, has similar clinical effects to propofol for sedation in general anaesthesia. However, it remains uncertain whether remimazolam could increase postoperative delirium (POD) compared with propofol.

OBJECTIVES

The purpose of our study was to compare the incidence of POD between remimazolam and propofol as sedative agents in general anaesthesia.

STUDY DESIGN

Systematic review and meta-analysis of randomised controlled trials (RCTs).

METHODS

PubMed, Embase, Cochrane Library, and Web of Science databases were searched for prospective RCTs published through September 16, 2024. RCTs reporting the incidence of POD and comparing remimazolam with propofol for general anaesthesia were included. Odds ratio (ORs) were calculated using a random-effects model. The primary outcome was the incidence of POD. The secondary outcomes included time to extubation, awakening time, and adverse events such as intraoperative hypotension.

RESULTS

A total of six RCTs involving 1107 patients were included in this meta-analysis. For the primary outcome, the incidence of POD did not differ between the remimazolam and propofol groups (OR, 0.92; 95 % confidence interval [CI], 0.58-1.44). Regarding the secondary outcomes, remimazolam was associated with a lower incidence of intraoperative hypotension compared with propofol (OR, 0.31; 95 % CI, 0.21-0.46). There were no significant differences in other secondary outcomes. In the sensitivity analysis on three RCTs including only older patients (≥60 years old), there was no significant difference in the incidence of POD (OR, 1.00; 95 % CI, 0.52-1.93).

CONCLUSION

Perioperative remimazolam administration did not increase POD and reduced the risk of intraoperative hypotension compared to propofol. Further large-scale RCTs are warranted to explore the association of remimazolam and POD. Systematic review protocol: PROSPERO CRD42024544122.

摘要

背景

瑞马唑仑是一种超短效苯二氮䓬类药物,在全身麻醉中作为镇静剂与丙泊酚具有相似的临床效果。然而,与丙泊酚相比,瑞马唑仑是否会增加术后谵妄(POD)仍不确定。

目的

我们研究的目的是比较瑞马唑仑和丙泊酚作为全身麻醉镇静剂时POD的发生率。

研究设计

对随机对照试验(RCT)进行系统评价和荟萃分析。

方法

检索了PubMed、Embase、Cochrane图书馆和Web of Science数据库,以查找截至2024年9月16日发表的前瞻性RCT。纳入报告POD发生率并比较瑞马唑仑与丙泊酚用于全身麻醉的RCT。采用随机效应模型计算优势比(OR)。主要结局是POD的发生率。次要结局包括拔管时间、苏醒时间以及术中低血压等不良事件。

结果

本荟萃分析共纳入6项涉及1107例患者的RCT。对于主要结局,瑞马唑仑组和丙泊酚组的POD发生率无差异(OR,0.92;95%置信区间[CI],0.58 - 1.44)。关于次要结局,与丙泊酚相比,瑞马唑仑与较低的术中低血压发生率相关(OR,0.31;95% CI,0.21 - 0.46)。其他次要结局无显著差异。在仅包括老年患者(≥60岁)的3项RCT的敏感性分析中,POD发生率无显著差异(OR,1.00;95% CI,0.52 - 1.93)。

结论

与丙泊酚相比,围手术期使用瑞马唑仑不会增加POD,且降低了术中低血压的风险。有必要进行进一步的大规模RCT来探究瑞马唑仑与POD之间的关联。系统评价方案:PROSPERO CRD42024544122。

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