Comparison of Perioperative Conscious Sedation During Endovascular Thrombectomy in Acute Ischemic Stroke (PEACE) A Randomised Multicentre Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 810
- 试验地点
- 6
- 主要终点
- The proportion of mRS score 0-2 at 90 days
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •Presenting with symptoms of acute ischemic stroke within 24 hours of last known well;
- •Computed tomography angiography or magnetic resonance angiography confirmed occlusion of the intracranial segment of the internal carotid artery, M1 or M2 segment of the middle cerebral artery;
- •Pre-stroke modified Rankin scale (mRS) score ≤ 2;
- •National Institutes of Health Stroke Scale (NIHSS) score ≥ 6 before randomization;
- •Alberta Stroke Program Early CT Score (ASPECTS) ≥ 3 prior to randomization;
- •The patient or their legal representative provides written informed consent.
排除标准
- •Pregnant or lactating women;
- •Known allergy to contrast agents or nitinol devices;
- •Known allergy to midazolam or other benzodiazepines;
- •Known allergy to dexmedetomidine or its components;
- •Long-term use of sedative medications, α2-adrenergic receptor agonists (such as clonidine), or potent CYP450 inhibitors or inducers before randomization;
- •Uncontrolled hypertension or hypotension (defined as systolic blood pressure > 185 mmHg or < 90 mmHg, diastolic blood pressure > 110 mmHg or < 60 mmHg) measured prior to randomization;
- •Second-degree or third-degree heart blockage or bradyarrhythmia with a baseline heart rate lower than 50 beats / min;
- •Any major surgery or serious trauma within 14 days;
- •Known genetic or acquired bleeding diathesis (platelet count < 100*10^9/L, activated partial thromboplastin time > 50 s or international normalized ratio > 1.7);
- •Blood glucose < 2.8 or > 22.2 mmol/L;
- •Severe renal insufficiency (defined as glomerular filtration rate < 30 ml/min or serum creatinine > 220 mmol/L [2.5mg/dl]);
- •Receiving hemodialysis or peritoneal dialysis;
- •Life expectancy ≤ 1 year;
- •Severe agitation or seizures;
- •Clinical manifestations of central nervous system vasculitis;
- •Premorbid neurological disease or mental disorders confounding evaluation;
- •Unwilling to be followed up within 90 days;
- •Participation in other interventional randomized clinical trials.
- •Imaging exclusion criteria
- •Evidence of intracranial hemorrhage on computed tomography (CT) or magnetic resonance imaging (MRI);
- •Cerebellar infarction with obvious space-occupying effects and fourth ventricle compression on CT or MRI;
- •Any untreated or incompletely treated intracranial aneurysm or any intracranial vascular malformation;
- •Bilateral occlusion or multiple intracranial vessels occlusions;
- •Intracranial tumors (with mass effect).
研究组 & 干预措施
the midazolam group
For patients allocated to the MDZ group, sedation will be initiated with an intravenous bolus of 0.05 mg/kg, drawn from a standard 1 mg/mL solution. A continuous maintenance infusion will then be started at a rate between 0.04 and 0.2 mg/kg/h, titrated to effect using an infusion pump. The infusion rate can be adjusted based on the sedation effect to achieve the appropriate level of sedation during EVT. If MDZ does not achieve satisfactory sedation during procedure, physicians or anesthesiologists may choose rescue sedation agents (such as propofol) or consider transitioning the patient to general anesthesia.
干预措施: Midazolam (Drug)
the dexmedetomidine group
For patients allocated to the DEX group, sedation will be induced with an intravenous loading dose of 1.0 μg/kg administered over 10 minutes, prepared from a standard 8 μg/mL solution. This will be immediately followed by a continuous maintenance infusion, delivered via pump at a rate ranging from 0.2 to 0.7 μg/kg/h, with adjustments made according to the desired clinical effect. If adequate sedation cannot be achieved with DEX alone, physicians or anesthesiologists are permitted to administer rescue sedation agents (such as propofol) or consider transitioning the patient to general anesthesia.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
The proportion of mRS score 0-2 at 90 days
时间窗: 90 days after randomization
mRS is short for modified Ranking score (ranging from 0 to 6, with higher values indicating a worse functional outcome).
次要结局
- EQ-5D-5L at 90 days(90 days after randomization)
- Shift in the distribution of mRS scores at 90 days(90 days after randomization)
- The proportion of mRS score 0-1 at 90 days(90 days after randomization)
- The proportion of mRS score 0-3 at 90 days(90 days after randomization)
- Rates of successful recanalization(Immediately after the thrombectomy procedure is completed)
- Score on the ASPECTS at 24-72 hours(24-72 hours after randomization)
- RASS score ≤ -3 during procedure(During operation)
- RASS score ≤ 0 during procedure(During operation)
- Changes of the GCS score at 24 hours(24 hours after randomization)
- Changes of the NIHSS score at 24 hours(24 hours after randomization)
- Changes of the GCS score at 5-7 days(5-7 days after randomization)
- Changes of the NIHSS score at 5-7 days(5-7 days after randomization)
- Barthel Index at 90 days(90 days after randomization)
研究者
Xinfeng Liu
Professor
Jinling Hospital, China