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.

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.

Impact of anesthesia modalities on functional outcome of mechanical thrombectomy in patients with acute ischemic stroke: a subgroup analysis of DIRECT-MT trial.

BACKGROUND: This subgroup analysis of Direct Intraarterial Thrombectomy in Order to Revascularize Acute Ischemic Stroke Patients with Large Vessel Occlusion Efficiently in Chinese Tertiary Hospitals Multicenter Randomized Clinical Trial (DIRECT-MT) aimed to investigate the influence of anesthesia modalities on the outcomes of endovascular treatment. METHODS: Patients were divided into two groups by receiving general anesthesia (GA) or non-general anesthesia (non-GA). The primary outcome was assessed by the between-group difference in the distribution of the modified Rankin Scale (mRS) at 90 days, estimated using the adjusted common odds ratio (acOR) by multivariable ordinal regression. Differences in workflow efficiency, procedural complication, and safety outcomes were analyzed. RESULTS: Totally 636 patients were enrolled (207 for GA and 429 for non-GA groups). There was no significant shift in the mRS distribution at 90 days between the two groups (acOR, 1.093). The median time from randomization to reperfusion was significantly longer in GA group (116 vs. 93 min, P < 0.0001). Patients in non-GA group were associated with a significantly lower NIHSS score at early stages (24 h, 11 vs 15; 5-7 days or discharge, 6.5 vs 10). The rate of severe manipulation-related complication did not differ significantly between GA and non-GA groups (0.97% vs 3.26%; P = 0.08). There are no differences in the rate of mortality and intracranial hemorrhage. CONCLUSIONS: In the subgroup analysis of DIRECT-MT, we found no significant difference in the functional outcome at 90 days between general anesthesia and non-general anesthesia, despite the workflow time being significantly delayed for patients with general anesthesia. Clinical trail registration clinicaltrials.gov Identifier: NCT03469206.