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SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke | Clinical Trials | Clareo Health

COMPLETEDPHASE4

SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke

SEGA - SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke - a Randomized Comparative Effectiveness Trial.

NCT03263117•The University of Texas Health Science Center, Houston

View on ClinicalTrials.gov

Summary

Objectives: This study aims to estimate overall treatment benefit (improvement in disability) among acute ischemic stroke patients that are randomized to General Anesthesia (GA) compared with Sedation (CS) during endovascular therapy. Assess safety (as measured by incidence of symptomatic intracranial hemorrhage); rates of Endovascular therapy (EVT) procedural complications, reperfusion; and quality of life. Hypothesis: GA during EVT for acute ischemic stroke improves functional outcomes at 90 days compared to sedation.

Eligibility

Age

18 - 90 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Acute ischemic stroke due to large intracranial vessel occlusion demonstrated on CT-angiography in the following anterior circulation locations that will be treated by endovascular therapy (EVT):
•1. Internal Carotid Artery (terminal "T" or "L-type"- occlusion)
•2. Middle Cerebral Artery (MCA) M1 or proximal M2
•3. Anterior Cerebral Artery (ACA) A1 or proximal A2
•* Patients who receive IV-tPA thrombolysis are eligible provided the drug was delivered within 4.5 hours of stroke onset or last seen normal and in accordance with local hospital standard of care.
•2. Ages 18-90.
•3. National Institute of Health Stroke Scale (NIHSS) score 6-30
•4. Time of from stroke symptom onset of last seen normal to start of EVT (defined as groin puncture) ≤ 16 hours.
•5. Limited infarct core, as defined below and adapted from the 2018 American Heart Association guidelines
•1. For patients presenting ≤ 6 hours from time of symptom onset or last seen normal, Alberta Stroke Program Early Computed Tomography Score (ASPECTS) ≥ 6
+6 more criteria

Exclusion Criteria

•1. Coma on admission (Glasgow Coma Scale \<8), need for intubation upon ED arrival, or transferred patients who present previously intubated.
•2. Severe agitation or seizures on admission that preclude safe vascular access.
•3. Loss of airway protective reflexes and/or vomiting on admission.
•4. Predicted or known difficult airway.
•5. Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia.
•6. Presumed septic embolus, or suspicion of bacterial endocarditis
•7. Currently participating or has participated in any investigational drug or device study within 30 days.
•8. Inability to follow-up for 90-day assessment.
•9. Known history of allergy to anesthesia drugs.
•10. Known history or family history of malignant hyperthermia

Locations (11)

Indiana University College of Medicine

Indianapolis, Indiana, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Henry Ford Health System

Louisville, Kentucky, United States

Rochester Regional Health

Rochester, New York, United States

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Geisinger Health

Danville, Pennsylvania, United States

Temple University

Philadelphia, Pennsylvania, United States

Memorial Hermann Hospital System - Memorial City Medical Center

Houston, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

University of Texas Health Science Center Houston with Memorial Hermann Hospital System - The Medical Center

Houston, Texas, United States

Key Dates

Start Date

July 1, 2018

Primary Completion Date

April 22, 2023

Completion Date

April 22, 2023

Last Updated

November 26, 2025

Enrollment

260

ACTUAL participants

Conditions

Stroke

Interventions

Sedation

DRUG

General Anesthesia (GA)

DRUG

Intra-arterial Thrombectomy

PROCEDURE

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Stroke Patients

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RECRUITINGPHASE1

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Ischemic Stroke

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke

Inclusion Criteria

Exclusion Criteria

Effects of Circuit Training Combining Different Types of Distal Robot-assisted and Task-oriented Therapy on Motor Control, Motor and Daily Functions, and Quality of Life After Stroke

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LWP779 in Healthy Participants

Cerebellar Stimulation for Aphasia Rehabilitation

Rapid Evacuation and Access of Cerebral Hemorrhage Trial

Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours

Mirror Therapy Rehabilitation of the Upper Limb After Stroke (NEURO-MIROIR 2)