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
- 招募中
- 发起方
- 入组人数
- 810
- 试验地点
- 2
- 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
- •CTA or MRA confirmed occlusion of the anterior circulation (intracranial carotid artery or M1, M2 segment of the middle cerebral artery)
- •Randomization finished within 24 hours of symptom onset or time last know well
- •Pre-stroke mRS score ≤2
- •NIHSS score ≥6 at the time of randomization
- •ASPECTS value ≥3
- •Informed consent signed
排除标准
- •General exclusion criteria
- •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
- •Planned to receive general anesthesia for EVT
- •Uncontrolled hypertension or hypotension (defined as systolic blood pressure >185 mmHg or < 90 mmHg, diastolic blood pressure >110 mmHg or < 60 mmHg)
- •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\*109 /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 less than 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
- •1. Evidence of intracranial hemorrhage on CT or 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 dexmedetomidine group
In the experimental group, dexmedetomidine is used for intraoperative sedation. Dexmedetomidine is prepared as an 8μg/ml intravenous infusion. It begins with an initial loading dose of 1μg/kg, administered over a period exceeding 10 minutes.If dexmedetomidine fails to achieve a satisfactory level of sedation during surgery, physicians may opt for rescue sedation with propofol or consider transferring the patient to general anesthesia. Propofol (20ml 0.2g) starts with a loading dose of 0.3mg/(kg*h) and a maintenance dose of 0.3-4mg/(kg*h). The infusion rate can be adjusted based on the sedation effect to achieve the appropriate level of sedation during EVT.
干预措施: Dexmedetomidine (Drug)
the midazolam group
In the control group, midazolam is used for intraoperative sedation. Midazolam is prepared as a 1mg/ml intravenous infusion. It starts with an initial intravenous push of 0.05mg/kg, followed by a maintenance dose of 0.04-0.2mg/kg administered intravenously via an infusion pump. If midazolam fails to achieve a satisfactory level of sedation during surgery, physicians may opt for rescue sedation with propofol or consider transferring the patient to general anesthesia. Propofol (20ml 0.2g) starts with a loading dose of 0.3mg/(kg*h) and a maintenance dose of 0.3-4mg/(kg*h). The infusion rate can be adjusted based on the sedation effect to achieve the appropriate level of sedation during EVT.
干预措施: Midazolam (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
- 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