Actively Recruiting
General Versus Regional Anesthesia for Carotid Endarterectomy at Acute Ischemic Stroke Trial
Led by Pirogov Russian National Research Medical University · Updated on 2026-03-27
100
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
General Versus Regional Anesthesia for Carotid Endarterectomy at Acute Ischemic Stroke Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ischemic stroke in the middle cerebral artery territory
- Ipsilateral stenosis of the internal carotid artery more than 50%
- Neurological deficit at the time of surgery with modified Rankin scale score 0-4
- NIH Stroke Scale score no more than 12
- Ischemia size no more than one-third of the middle cerebral artery territory
- Surgery planned between 1 and 28 days after ischemic stroke
- Age between 40 and 80 years
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 1 location
1
Pryamikov Aleksandr
Moscow, Russia
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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