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Clinical Trials/NCT06175715
NCT06175715
Recruiting
Not Applicable

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.

Pirogov Russian National Research Medical University1 site in 1 country100 target enrollmentJuly 1, 2024

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:

  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).
Registry
clinicaltrials.gov
Start Date
July 1, 2024
End Date
December 31, 2028
Last Updated
last year
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Sponsor
Pirogov Russian National Research Medical University
Responsible Party
Sponsor

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

Study Sites (1)

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