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Two sedatives, one question: can remimazolam shield the brain during aortic arch surgery?

NCT ID NCT07816068

Symptom relief Sponsor: Seoul National University Hospital Source: ClinicalTrials.gov ↗

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

Aortic arch surgery temporarily cuts blood flow to the brain, which can leave patients with lasting thinking and memory problems. Researchers at Seoul National University Hospital are testing whether anesthesia with remimazolam, rather than propofol, lowers the chance of that cognitive decline. The trial enrolls 80 adults scheduled for aortic arch replacement and measures their thinking scores before surgery and again about a week later. Blood tests track inflammation and nerve injury markers to see whether remimazolam has any protective effect on the brain.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
remimazolam, a sedative drug used during anesthesia, compared with propofol
What this could lead to
If remimazolam protects the brain better than propofol, hospitals could choose it for aortic arch surgery and reduce confusion and memory problems after these operations.
What could go wrong
The trial is small, with 80 patients at one hospital, and it measures thinking scores and blood markers rather than long-term recovery. Any difference between the two drugs may be too small to matter, and the results may not apply to other hospitals or other types of heart surgery.

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

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Nov 2027

An estimate. End dates often move.

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

19 years and older

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: * Adults aged 19 years or older * Patients scheduled to undergo total or partial aortic arch replacement for aortic arch disease, with planned circulatory arrest and/or selective cerebral perfusion as a cerebral protection strategy during surgery Exclusion Criteria: * Pre-existing cognitive impairment, defined as Mini-Mental State Examination (MMSE) score \<24 * Acute cerebral hemorrhage or cerebral infarction within the previous 3 months * History of hypersensitivity to remimazolam or other benzodiazepines * History of alcohol or substance abuse * Chronic use of opioids or benzodiazepines * Severe hepatic impairment (Child-Pugh class C) * Acute or chronic renal failure requiring dialysis Emergency surgery or acute aortic dissection

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Conditions

The condition(s) this trial relates to.

Aneurysm, Aortic Arch Emergence Delirium thoracic aortic aneurysm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic aneurysm of the proximal arch Aortic aneurysms arch Aortic arch disease Postoperative delirium Postoperative delirium (POD) Postoperative delirium and postoperative cognitive decline

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Seoul National University Hospital

    Seoul, 03080, South Korea

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