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Stroke treatment showdown: sedation or anesthesia?

NCT ID NCT03263117

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

260 people

The number who actually took part.

Started

Jul 2018

Finished

Apr 2023

Lead sponsor

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

18 to 90 years

Sex

Anyone

Healthy volunteers

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

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

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Geisinger Health

    Danville, Pennsylvania, 17822, United States

  • Henry Ford Health System

    Louisville, Kentucky, 48150, United States

  • Indiana University College of Medicine

    Indianapolis, Indiana, 46202, United States

  • Memorial Hermann Hospital System - Memorial City Medical Center

    Houston, Texas, 77024, United States

  • Memorial Hermann Hospital System - The Woodlands Medical Center

    The Woodlands, Texas, 77380, United States

  • Rochester Regional Health

    Rochester, New York, 14617, United States

  • Temple University

    Philadelphia, Pennsylvania, 19122, United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242, United States

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

    Houston, Texas, 77030, United States

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157, United States

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