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

Not Applicable

Recruiting

• Conditions: Acute Ischemic Stroke
• Interventions: Procedure: carotid endarterectomy

• Registration Number: NCT06175715
• Lead Sponsor: Pirogov Russian National Research Medical University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-01
• Study First Submitted QC: 2023-12-15
• Study First Posted: 2023-12-19
• Study Start: 2024-07-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07
• Primary Completion: 2026-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
General anesthesia for carotid endarterectomy in patients with acute stage of ischemic stroke.	carotid endarterectomy	-
Regional anesthesia for carotid endarterectomy in patients with acute stage of ischemic stroke.	carotid endarterectomy	-

Primary Outcome Measures

Name	Time	Method
Rate of perioperative ipsilateral ischemic stroke (%)	in hospital, 30-day, 1 year
Rate of Myocardial infarction (%)	in hospital, 30-day, 1 year
Rate of main adverse cardiovascular events (%)	in hospital, 30-day, 1 year
Rate of any stroke (%)	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

Trial Locations

Locations (1)

Pryamikov Aleksandr; 🇷🇺 Moscow, Russian Federation