Acute Ischemic Stroke
Conditions
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: 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).
Interventions
PROCEDUREcarotid endarterectomy
carotid endarterectomy under local or general anethesia
Sponsors
Pirogov Russian National Research Medical University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | 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 |
Countries
Russia
Outcome results
None listed