Stroke treatment showdown: sedation or anesthesia?
NCT ID NCT03263117
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at 260 people having emergency stroke treatment to remove a clot. Some were given sedation (awake but relaxed) and others were put under general anesthesia (completely asleep). The goal was to see which approach leads to better recovery and fewer complications after 90 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sedation drugs (fentanyl, midazolam, dexmedetomidine, propofol) or general anesthesia
- What this could lead to
- If it works, this could show that one type of anesthesia during stroke treatment leads to better recovery and less disability.
- What could go wrong
- This is a completed Phase 4 trial, but results may not apply to all stroke patients or settings. The choice of sedation drugs was not strictly controlled, which could affect outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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260 people
The number who actually took part.
- Started
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Jul 2018
- Finished
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Apr 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 2. 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. 6. Subject willing/able to return for protocol required follow up visits. 7. No significant pre-stroke disability (modified Rankin Score must be ≤ 2). 8. Females of childbearing potential must have a negative serum or urine pregnancy test. 9. Patient or patient's legally authorized representative has given Informed Consent according to Good Clinical Practices (GCP) and/or local IRB policies. 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Baylor College of Medicine
Houston, Texas, 77030, United States
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Geisinger Health
Danville, Pennsylvania, 17822, United States
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Henry Ford Health System
Louisville, Kentucky, 48150, United States
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Indiana University College of Medicine
Indianapolis, Indiana, 46202, United States
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Memorial Hermann Hospital System - Memorial City Medical Center
Houston, Texas, 77024, United States
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Memorial Hermann Hospital System - The Woodlands Medical Center
The Woodlands, Texas, 77380, United States
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Rochester Regional Health
Rochester, New York, 14617, United States
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Temple University
Philadelphia, Pennsylvania, 19122, United States
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University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
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University of Texas Health Science Center Houston with Memorial Hermann Hospital System - The Medical Center
Houston, Texas, 77030, United States
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Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
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