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

Pirogov Russian National Research Medical University

Status: Enrolling

Conditions: Acute Ischemic Stroke

Treatments: Procedure: carotid endarterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06175715

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Details and patient eligibility

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).

Enrollment: 100 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Regional anesthesia for carotid endarterectomy in patients with acute stage of ischemic stroke.

Active Comparator group

Treatment:

Procedure: carotid endarterectomy

General anesthesia for carotid endarterectomy in patients with acute stage of ischemic stroke.

Active Comparator group

Treatment:

Procedure: carotid endarterectomy