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

Last updated: November 5, 2024
Sponsor: Pirogov Russian National Research Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cardiac Ischemia

Blood Clots

Treatment

carotid endarterectomy

Clinical Study ID

NCT06175715
1
  • Ages 40-80
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Ischemic stroke in the middle cerebral artery territory 2. Ipsilateral stenosisof the internal carotid artery more than 50% 3. Neurological deficit at thetime of surgical treatment: the modified Rankin scale (mRs) score of 0-4 andthe US National Institutes of Health (NIHSS) stroke scale score no more than 12
  2. The size of the ischemia focus: no more than 1/3 in the territory of themiddle cerebral artery brain supply 5. Terms of operation: from 1 to 28 daysfrom the moment of ischemic stroke

Exclusion

Exclusion Criteria:

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: carotid endarterectomy
Phase:
Study Start date:
July 01, 2024
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • Pryamikov Aleksandr

    Moscow,
    Russian Federation

    Active - Recruiting

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