The Study is Planned to Evaluate the Effectiveness and Safety of Two Types of Anesthesia (Regional and General) for Carotid Endarterectomy in 100 Patients With Acute Stage of Stroke: 50 Patients Will be Operated Under Regional Anesthesia and the Remaining 50 Patients Under General Anesthesia.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Rate of perioperative ipsilateral ischemic stroke (%)
研究概览
简要总结
The study is planned to evaluate the effectiveness and safety of two types of anesthesia (regional and general) for carotid endarterectomy in 100 patients with acute stage of stroke: 50 patients will be operated under regional anesthesia and the remaining 50 patients under general anesthesia.
Patient inclusion criteria:
- Ischemic stroke in the middle cerebral artery territory
- Ipsilateral stenosis of the internal carotid artery more than 50%
- Neurological deficit at the time of surgical treatment: the modified Rankin scale (mRs) score of 0-4 and the US National Institutes of Health (NIHSS) stroke scale score no more than 12
- The size of the ischemia focus: no more than 1/3 in the territory of the middle cerebral artery brain supply
- Terms of operation: from 1 to 28 days from the moment of ischemic stroke
The primary intra-hospital and/or 30-day study endpoints:
- Perioperative ipsilateral ischemic stroke.
- Any stroke: contralateral ischemic or any hemorrhagic stroke.
- Myocardial infarction.
- Hemorrhagic complications that required surgical revision of the operating wound or transfusion of blood components.
- Surgical site infection
- Death
- Main adverse cardiovascular events (stroke + myocardial infarction + death).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Ischemic stroke in the middle cerebral artery territory
- •Ipsilateral stenosis of the internal carotid artery more than 50%
- •Neurological deficit at the time of surgical treatment: the modified Rankin scale (mRs) score of 0-4 and the US National Institutes of Health (NIHSS) stroke scale score no more than 12
- •The size of the ischemia focus: no more than 1/3 in the territory of the middle cerebral artery brain supply
- •Terms of operation: from 1 to 28 days from the moment of ischemic stroke
排除标准
- 未提供
结局指标
主要结局
Rate of perioperative ipsilateral ischemic stroke (%)
时间窗: in hospital, 30-day, 1 year
Rate of Hemorrhagic complications (%)
时间窗: in hospital, 30-day, 1 year
Rate of Surgical site infection (%)
时间窗: in hospital, 30-day, 1 year
Rate of Myocardial infarction (%)
时间窗: in hospital, 30-day, 1 year
Rate of main adverse cardiovascular events (%)
时间窗: in hospital, 30-day, 1 year
Rate of any stroke (%)
时间窗: in hospital, 30-day, 1 year
Rate of Death (%)
时间窗: in hospital, 30-day, 1 year
次要结局
未报告次要终点
