SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke

Completed · Phase 4

Conditions studied: Stroke

In brief

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.

Key facts

Study ID

NCT03263117

Run by

The University of Texas Health Science Center, Houston

People needed

260

Starts

2018-07-01

Expected to finish

2023-04-22

Last updated by the study team

2025-11-26

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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):
• Internal Carotid Artery (terminal "T" or "L-type"- occlusion)
• Middle Cerebral Artery (MCA) M1 or proximal M2
• 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.
• Ages 18-90.
• National Institute of Health Stroke Scale (NIHSS) score 6-30
• Time of from stroke symptom onset of last seen normal to start of EVT (defined as groin puncture) ≤ 16 hours.
• Limited infarct core, as defined below and adapted from the 2018 American Heart Association guidelines
• For patients presenting ≤ 6 hours from time of symptom onset or last seen normal, Alberta Stroke Program Early Computed Tomography Score (ASPECTS) ≥ 6
• For patients presenting > 6 hours and ≤ 16 hours from time of symptom onset or last seen normal, they must satisfy EITHER ONE of the two following criteria:
• i. Ischemic core by CT Perfusion or MRI/MR Perfusion < 70 mL, a ratio of volume of penumbral tissue to infarct core of ≥ 1.8, and and absolute volume of penumbral tissue of ≥ 15 mL OR ii. For patients with NIHSS ≥ 10, infarct core of < 31 mL by CT Perfusion or MRI; For patients with NIHSS ≥ 20, infarct core < 51 mL.
• Subject willing/able to return for protocol required follow up visits.
• No significant pre-stroke disability (modified Rankin Score must be ≤ 2).
• Females of childbearing potential must have a negative serum or urine pregnancy test.
• Patient or patient's legally authorized representative has given Informed Consent according to Good Clinical Practices (GCP) and/or local IRB policies.

You may not qualify if…

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

Where it is running

• 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
• Memorial Hermann Hospital System - The Woodlands Medical Center — The Woodlands, Texas, United States

Full record on ClinicalTrials.gov

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