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

NCT ID: NCT06175715

Last Updated: 2024-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2028-12-31

Brief Summary

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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

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Conditions

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Acute Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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

Group Type ACTIVE_COMPARATOR

carotid endarterectomy

Intervention Type PROCEDURE

carotid endarterectomy under local or general anethesia

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

Group Type ACTIVE_COMPARATOR

carotid endarterectomy

Intervention Type PROCEDURE

carotid endarterectomy under local or general anethesia

Interventions

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carotid endarterectomy

carotid endarterectomy under local or general anethesia

Intervention Type PROCEDURE

Eligibility Criteria

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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

\-
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pirogov Russian National Research Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pryamikov Aleksandr

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Facility Contacts

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Aleksandr Pryamikov

Role: primary

89032862552

Other Identifiers

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1

Identifier Type: -

Identifier Source: org_study_id

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