Regional or General Anesthesia for Carotid Endarterectomy in Patients With Acute Stage of Ischemic Stroke.

Study Overview
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Brief Summary
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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).

Official Title
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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.

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Procedure: carotid endarterectomy


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Regional anesthesia for carotid endarterectomy in patients with acute stage of ischemic stroke.<br> | Procedure: carotid endarterectomy<br>* carotid endarterectomy under local or general anethesia<br>|
| Active Comparator: General anesthesia for carotid endarterectomy in patients with acute stage of ischemic stroke.<br> | Procedure: carotid endarterectomy<br>* carotid endarterectomy under local or general anethesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of perioperative ipsilateral ischemic stroke (%) |  | in hospital, 30-day, 1 year | 
| Rate of any stroke (%) |  | in hospital, 30-day, 1 year | 
| Rate of Myocardial infarction (%) |  | in hospital, 30-day, 1 year | 
| Rate of Hemorrhagic complications (%) |  | in hospital, 30-day, 1 year | 
| Rate of Surgical site infection (%) |  | in hospital, 30-day, 1 year | 
| Rate of Death (%) |  | in hospital, 30-day, 1 year | 
| Rate of main adverse cardiovascular events (%) |  | in hospital, 30-day, 1 year |