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

Acute Ischemic Stroke Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06175715
• Other study ID #: 1
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: November 2023
• Source: Pirogov Russian National Research Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Procedure:
• carotid endarterectomy
carotid endarterectomy under local or general anethesia

Locations

Country	Name	City	State
Russian Federation	Pryamikov Aleksandr	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Pirogov Russian National Research Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

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