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甲苯磺酸瑞马唑仑用于骨科手术脊麻-硬膜外联合麻醉镇静的安全性和有效性:一项随机对照试验。

Safety and effcacy of remimazolam tosilate for sedation during combined spinal-epidural anesthesia for orthopedic procedures: a randomized controlled trial.

机构信息

Department of Anesthesiology, Renmin Hospital,Hubei University of Medicine, Shiyan City, Hubei Province, China.

出版信息

BMC Anesthesiol. 2024 Feb 26;24(1):75. doi: 10.1186/s12871-024-02451-7.

DOI:10.1186/s12871-024-02451-7
PMID:38408901
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10895730/
Abstract

OBJECTIVE

The objective of this study was to assess the efficacy and safety of Remimazolam in the context of combined spinal-epidural anesthesia for sedation during orthopedic surgery.

METHODS

This randomized controlled trial enrolled patients scheduled for orthopedic surgery under combined spinal-epidural anesthesia (N = 80), who were randomly allocated to receive either dexmedetomidine (Group-D) or remimazolam (Group-R). The target sedation range aimed for a Ramsay score of 2-5 or a BIS value of 60-80 to evaluate the effectiveness and safety of remimazolam during sedation.

RESULTS

The time taken to achieve the desired level of sedation was significantly shorter in the remimazolam group compared to the dexmedetomidine group (3.69 ± 0.75 vs. 9.59 ± 1.03; P < 0.0001). Patients in the remimazolam group exhibited quicker recovery, fewer intraoperative adverse events, more consistent vital signs, and greater satisfaction at various time points throughout the surgery.

CONCLUSION

This preliminary study demonstrates that remimazolam tosilate serves as a safe and effective sedative for orthopedic surgery performed under combined spinal-epidural anesthesia, in comparison with dexmedetomidine.

摘要

目的

本研究旨在评估瑞马唑仑在联合椎管内麻醉镇静下用于骨科手术中的疗效和安全性。

方法

这是一项随机对照试验,纳入了 80 例拟在联合椎管内麻醉下接受骨科手术的患者,他们被随机分配接受右美托咪定(D 组)或瑞马唑仑(R 组)。目标镇静范围旨在达到 Ramsay 评分 2-5 或 BIS 值 60-80,以评估瑞马唑仑在镇静期间的有效性和安全性。

结果

与右美托咪定组相比,瑞马唑仑组达到所需镇静水平的时间明显缩短(3.69±0.75 对 9.59±1.03;P<0.0001)。瑞马唑仑组患者的恢复更快,术中不良事件更少,生命体征更稳定,在手术各个时间点的满意度更高。

结论

这项初步研究表明,与右美托咪定相比,甲苯磺酸瑞马唑仑在联合椎管内麻醉下用于骨科手术是一种安全有效的镇静剂。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/11ec/10895730/62fa706eaa96/12871_2024_2451_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/11ec/10895730/265d05b508fc/12871_2024_2451_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/11ec/10895730/90453af0f1a2/12871_2024_2451_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/11ec/10895730/9e6c84484c5f/12871_2024_2451_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/11ec/10895730/62fa706eaa96/12871_2024_2451_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/11ec/10895730/265d05b508fc/12871_2024_2451_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/11ec/10895730/90453af0f1a2/12871_2024_2451_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/11ec/10895730/9e6c84484c5f/12871_2024_2451_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/11ec/10895730/62fa706eaa96/12871_2024_2451_Fig4_HTML.jpg

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