General Versus Regional Anesthesia for Carotid Endarterectomy at Acute Ischemic Stroke Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorPirogov Russian National Research Medical University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

  • carotid endarterectomy

    Procedure/Surgery

    carotid endarterectomy under local or general anethesia

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Regional anesthesia for carotid endarterectomy in patients with acute stage of ischemic stroke.Active comparator 1 intervention
Group B: General anesthesia for carotid endarterectomy in patients with acute stage of ischemic stroke.Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate of perioperative ipsilateral ischemic stroke (%)

Time frame
in hospital, 30-day, 1 year
2

Rate of any stroke (%)

Time frame
in hospital, 30-day, 1 year
3

Rate of Myocardial infarction (%)

Time frame
in hospital, 30-day, 1 year
4

Rate of Hemorrhagic complications (%)

Time frame
in hospital, 30-day, 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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