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临床试验/NCT06175715
NCT06175715招募中不适用

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.

Pirogov Russian National Research Medical University2 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2024年7月1日最近更新:
适应症

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:

  1. Ischemic stroke in the middle cerebral artery territory
  2. Ipsilateral stenosis of the internal carotid artery more than 50%
  3. 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
  4. The size of the ischemia focus: no more than 1/3 in the territory of the middle cerebral artery brain supply
  5. Terms of operation: from 1 to 28 days from the moment of ischemic stroke

The primary intra-hospital and/or 30-day study endpoints:

  1. Perioperative ipsilateral ischemic stroke.
  2. Any stroke: contralateral ischemic or any hemorrhagic stroke.
  3. Myocardial infarction.
  4. Hemorrhagic complications that required surgical revision of the operating wound or transfusion of blood components.
  5. Surgical site infection
  6. Death
  7. 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

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

研究者

发起方
Pirogov Russian National Research Medical University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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