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瑞马唑仑与丙泊酚对急性缺血性卒中血管内血栓切除术的影响:一项随机对照试验的研究方案

The Effects of Remimazolam versus Propofol on Endovascular Thrombectomy for Acute Ischemic Stroke: Study Protocol for a Randomized Controlled Trial.

作者信息

Fu Lijuan, Zhou Rui, Jiang Wencai, Lan Lan, Chen Xuemeng, Cao Yuansheng, Xia Leqiang, Zhou Yukai, Han Jia, Zhou Dan, Zhang Xianjie

机构信息

Department of Anesthesiology, Deyang People's Hospital, Deyang City, Sichuan Province, People's Republic of China.

Department of Anesthesiology and Perioperative Medicine, Shanghai Fourth People's Hospital, School of Medicine, Tongji University, Shanghai City, People's Republic of China.

出版信息

Vasc Health Risk Manag. 2024 Dec 3;20:533-539. doi: 10.2147/VHRM.S486834. eCollection 2024.

DOI:10.2147/VHRM.S486834
PMID:39651401
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11625192/
Abstract

BACKGROUND

While general anesthesia has been widely used in endovascular thrombectomy for acute ischemic stroke (AIS), the optimal anesthesia medication for hemodynamic management remains unclear.

PURPOSE

To compare the effects of remimazolam and propofol on endovascular thrombectomy for AIS.

METHODS

This study is a single-center, double-blind and randomized controlled trial. Eligible patients will be randomly allocated into the remimazolam group and propofol group. Remimazolam and propofol will be administered to induce and maintain anesthesia respectively. The primary outcome is the incidence of intraoperative hypotension. The secondary outcomes include frequency of hypotension, the largest difference value of mean arterial pressure (MAP), dosage of vasopressors, extubation time, operation time, modified thrombolysis in cerebral infarction (mTICI) level, National Institutes of Health Stroke Scale (NIHSS) score and modified Rankin scale (mRS) score.

CONCLUSION

This study evaluates the influences of remimazolam versus propofol on endovascular therapy for AIS patients. Results of this study are expected to provide more evidence of the choice of anesthetics in this kind of operation.

TRIAL REGISTRATION

This study has been registered at the Chinese Clinical Trial Registry (ChiCTR2300076880).

摘要

背景

虽然全身麻醉已广泛应用于急性缺血性卒中(AIS)的血管内血栓切除术,但用于血流动力学管理的最佳麻醉药物仍不明确。

目的

比较瑞米唑仑和丙泊酚对AIS血管内血栓切除术的影响。

方法

本研究为单中心、双盲、随机对照试验。符合条件的患者将被随机分配到瑞米唑仑组和丙泊酚组。分别给予瑞米唑仑和丙泊酚诱导和维持麻醉。主要结局是术中低血压的发生率。次要结局包括低血压发生频率、平均动脉压(MAP)的最大差值、血管升压药用量、拔管时间、手术时间、改良脑梗死溶栓(mTICI)分级、美国国立卫生研究院卒中量表(NIHSS)评分和改良Rankin量表(mRS)评分。

结论

本研究评估瑞米唑仑与丙泊酚对AIS患者血管内治疗的影响。本研究结果有望为这类手术中麻醉剂的选择提供更多证据。

试验注册

本研究已在中国临床试验注册中心注册(ChiCTR2300076880)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6f5f/11625192/4bf39b946282/VHRM-20-533-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6f5f/11625192/788b2b631110/VHRM-20-533-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6f5f/11625192/4bf39b946282/VHRM-20-533-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6f5f/11625192/788b2b631110/VHRM-20-533-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6f5f/11625192/4bf39b946282/VHRM-20-533-g0002.jpg

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本文引用的文献

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Drug Des Devel Ther. 2024 May 29;18:1907-1915. doi: 10.2147/DDDT.S455915. eCollection 2024.
2
Comparison of remimazolam-based and propofol-based total intravenous anesthesia on hemodynamics during anesthesia induction in patients undergoing transcatheter aortic valve replacement: a randomized controlled trial.比较瑞马唑仑和依托咪酯全身静脉麻醉对行经导管主动脉瓣置换术患者麻醉诱导期间血流动力学的影响:一项随机对照试验。
J Anesth. 2024 Jun;38(3):330-338. doi: 10.1007/s00540-024-03311-x. Epub 2024 Feb 12.
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Remimazolam propofol for procedural sedation: a meta-analysis of randomized controlled trials.瑞马唑仑与丙泊酚用于操作镇静:随机对照试验的荟萃分析。
PeerJ. 2023 Jun 12;11:e15495. doi: 10.7717/peerj.15495. eCollection 2023.
4
Outcomes After Endovascular Therapy With Procedural Sedation vs General Anesthesia in Patients With Acute Ischemic Stroke: The AMETIS Randomized Clinical Trial.血管内治疗伴程序性镇静与全身麻醉对急性缺血性脑卒中患者结局的影响:AMETIS 随机临床试验。
JAMA Neurol. 2023 May 1;80(5):474-483. doi: 10.1001/jamaneurol.2023.0413.
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Neurol Res Pract. 2023 Mar 30;5(1):12. doi: 10.1186/s42466-023-00238-8.
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