This study aims to conduct a multicenter, prospective, randomized clinical trial to scientifically evaluate the safety and efficacy of different perioperative sedation methods during endovascular thrombectomy in acute ischemic stroke patients with large vessel occlusion in the anterior circulation.
In the perioperative period of endovascular thrombectomy, the main sedation options are midazolam (MDZ) and dexmedetomidine (DEX). Research has shown that both sedation methods have their advantages and disadvantages, and there is no consensus on how to choose between them. Therefore, this study aims to conduct a multicenter, prospective, randomized clinical trial to scientifically evaluate the safety and efficacy of different perioperative sedation methods during endovascular thrombectomy (EVT) in AIS patients with large vessel occlusion in the anterior circulation and hopes to contribute to the advancement of EVT in clinical practice. In this trial, acute ischemic stroke patients with large vessel occlusion in the anterior circulation within 24 hours of symptom onset or last known well will be included. In the screening stage, participants who meet the inclusion criteria of the trial, upon completion of screening/baseline assessment and after signing the informed consent, will be randomly assigned in a 1:1 ratio to one of the following two treatment groups: the dexmedetomidine and midazolam conscious sedation groups. The primary end point is the proportion of modified Ranking score of 0-2 at 90 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
810
Patients receive perioperative sedation with dexmedetomidine
Patients receive perioperative sedation with midazolam
Jinling Hospital, Medical School of Nanjing University
Nanjing, None Selected, China
RECRUITINGThe General Hospital of Western Theater Command PLA
Chengdu, China
RECRUITINGThe proportion of mRS score 0-2 at 90 days
mRS is short for modified Ranking score (ranging from 0 to 6, with higher values indicating a worse functional outcome).
Time frame: 90 days after randomization
Shift in the distribution of mRS scores at 90 days
mRS is short for modified Ranking score (ranging from 0 to 6, with higher values indicating a worse functional outcome).
Time frame: 90 days after randomization
The proportion of mRS score 0-1 at 90 days
mRS is short for modified Ranking score (ranging from 0 to 6, with higher values indicating a worse functional outcome).
Time frame: 90 days after randomization
The proportion of mRS score 0-3 at 90 days
mRS is short for modified Ranking score (ranging from 0 to 6, with higher values indicating a worse functional outcome).
Time frame: 90 days after randomization
Rates of successful recanalization
Successful recanalization is defined as mTICI≥2b. mTICI is short for modified Thrombolysis in cerebral Infarction (ranging from 0 to 3, with higher values indicating a better reperfusion state).
Time frame: Immediately after the thrombectomy procedure is completed
Score on the ASPECTS at 24-72 hours
ASPECTS is short for Alberta Stroke Program Early CT Score (ranging from 0 to 10, with a higher score indicating a better perfusion state).
Time frame: 24-72 hours after randomization
RASS score ≤ -3 during procedure
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Deep sedation defined as RASS score ≤ -3. RASS is short for Richmond Agitation and Sedation Scale. RASS is a score of the degree of sedation (range from -5 to +4, higher values indicate a worse sedation state).
Time frame: During operation
RASS score ≤ 0 during procedure
Under sedation defined as RASS score ≤ 0. RASS is short for Richmond Agitation and Sedation Scale. RASS is a score of the degree of sedation (range from -5 to +4, higher values indicate a worse sedation state).
Time frame: During operation
Changes of the GCS score at 24 hours
GCS is short for Glasgow Coma Scale. GCS is a score of the degree of comma (range from 3 to 15, higher values indicate more severe comma).
Time frame: 24 hours after randomization
Changes of the NIHSS score at 24 hours
NIHSS is short for National Institute of Health stroke scale. NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits).
Time frame: 24 hours after randomization
Changes of the GCS score at 5-7 days
GCS is short for Glasgow Coma Scale. GCS is a score of the degree of comma (range from 3 to 15, higher values indicate more severe comma).
Time frame: 5-7 days after randomization
Changes of the NIHSS score at 5-7 days
NIHSS is short for National Institute of Health stroke scale. NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits).
Time frame: 5-7 days after randomization
Barthel Index at 90 days
Barthel Index is an ordinal disability score of 10 categories (range from 0 to 100, higher values indicate better prognosis)
Time frame: 90 days after randomization