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全麻下血管内治疗急性缺血性脑卒中患者的术中强化血压管理策略与结局:一项前瞻性随机对照试验的研究方案。

Intraoperative intensive blood pressure management strategy and the outcome of patients who had an acute ischaemic stroke undergoing endovascular treatment under general anaesthesia: study protocol for a prospective randomised controlled trial.

机构信息

Faculty of Anesthesiology, Changhai Hospital, Naval Medical University, Shanghai, China.

Faculty of Anesthesiology, Changhai Hospital, Naval Medical University, Shanghai, China

出版信息

BMJ Open. 2024 Apr 3;14(4):e079197. doi: 10.1136/bmjopen-2023-079197.

Abstract

UNLABELLED

BackgroundEndovascular thrombectomy is the recommended treatment for acute ischaemic stroke, but the optimal blood pressure management strategy during the procedure under general anaesthesia remains controversial. In this study protocol, we propose an intraoperative intensive blood pressure range (110-140 mm Hg systolic blood pressure) based on a retrospective analysis and extensive literature review. By comparing the outcomes of patients who had an acute ischaemic stroke undergoing mechanical thrombectomy under general anaesthesia with standard blood pressure management (140-180 mm Hg systolic blood pressure) versus intensive blood pressure management, we aim to determine the impact of intraoperative intensive blood pressure management strategy on patient prognosis.

METHODS AND ANALYSIS

The study is a double-blinded, randomised, controlled study, with patients randomised into either the standard blood pressure management group or the intensive blood pressure management group. The primary endpoint of the study will be the sequential analysis of modified Rankin Scale scores at 90 days after mechanical thrombectomy.

ETHICS AND DISSEMINATION

The study has been approved by the ethics committee of Shanghai Changhai Hospital with an approval number CHEC2023-015. The results of the study will be published in peer-reviewed international journals.

TRIAL REGISTRATION NUMBER

ChiCTR2300070764.

摘要

背景:血管内血栓切除术是急性缺血性脑卒中的推荐治疗方法,但在全身麻醉下进行手术时,最佳血压管理策略仍存在争议。在本研究方案中,我们基于回顾性分析和广泛的文献回顾,提出了术中强化血压范围(收缩压 110-140mmHg)。通过比较急性缺血性脑卒中患者在全身麻醉下接受机械取栓术时采用标准血压管理(收缩压 140-180mmHg)与强化血压管理的结果,我们旨在确定术中强化血压管理策略对患者预后的影响。

方法与分析:该研究是一项双盲、随机、对照研究,将患者随机分为标准血压管理组或强化血压管理组。研究的主要终点将是机械取栓术后 90 天改良 Rankin 量表评分的序贯分析。

伦理与传播:该研究已获得上海长海医院伦理委员会的批准,注册号为 CHEC2023-015。研究结果将发表在同行评议的国际期刊上。

临床试验注册号:ChiCTR2300070764。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0118/11146376/a174108d66ff/bmjopen-2023-079197f01.jpg

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