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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Ischemic Stroke
- Sponsor
- Pirogov Russian National Research Medical University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Rate of perioperative ipsilateral ischemic stroke (%)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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).
Investigators
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Rate of perioperative ipsilateral ischemic stroke (%)
Time Frame: in hospital, 30-day, 1 year
Rate of Hemorrhagic complications (%)
Time Frame: in hospital, 30-day, 1 year
Rate of Surgical site infection (%)
Time Frame: in hospital, 30-day, 1 year
Rate of Myocardial infarction (%)
Time Frame: in hospital, 30-day, 1 year
Rate of main adverse cardiovascular events (%)
Time Frame: in hospital, 30-day, 1 year
Rate of any stroke (%)
Time Frame: in hospital, 30-day, 1 year
Rate of Death (%)
Time Frame: in hospital, 30-day, 1 year