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Can a common sedative shield your brain after bypass surgery?

NCT ID NCT04289142

Disease control Sponsor: Sunnybrook Health Sciences Centre Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This large trial tests whether the sedative dexmedetomidine can prevent long-term memory and thinking problems that often follow heart surgery. Researchers will give the drug to 2,400 adults aged 60 and older during and after their operation, then track their cognitive function for a year. The goal is to find a simple way to protect brain health in cardiac patients.

What this could mean

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

Active substance
Dexmedetomidine (a sedative drug)
What this could lead to
If it works, this could point toward a way to prevent lasting memory and thinking problems after heart surgery.
What could go wrong
This is a single-drug trial in a specific surgery setting, so results may not apply to other procedures or sedatives. Cognitive outcomes can be influenced by many factors beyond the drug.

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 2,400 people

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

Started

Dec 2019

Expected to finish

Mar 2029

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

60 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: * Planned CABG (+/- valve, including off-pump) or valve replacement via sternotomy/thoracotomy, with initial recovery in the Cardiovascular Intensive Care Unit (CVICU) * Age ≥60 Exclusion Criteria: * Lack of patient consent * Pre-operative major cognitive dysfunction (CogState Brief Battery score \< 80) at screening * Aortic arch replacement/re-implantation (surgery requiring hypothermic circulatory arrest, e.g. Bentall procedure) * Allergy/contraindication to dexmedetomidine (untreated 2nd degree type 2 or 3rd degree heart block (pacemaker), cirrhosis, HR \< 50 , grade 4 LV, renal failure or on renal replacement therapy) * Unlikely to comply with study assessments (e.g. no fixed address, cannot complete cognitive tests at the 3, 6, and 12 month time points)

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Conditions

The condition(s) this trial relates to.

Cognition Disorders cognitive disorder Cognitive Dysfunction Confusion coronary artery disorder delirium heart valve disorder mental disorder nervous system disorder Neurobehavioral Manifestations Neurologic Manifestations psychiatric disorder Signs and Symptoms

As listed by the trial registrant

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

Analgesics Analgesics, non-narcotic Central nervous system depressants Cognition disorder Cognitive dysfunction Confusion Delirium Dexmedetomidine Hypnotics and sedatives Mental disorders Molecular mechanisms of pharmacological action Nervous system diseases Neurobehavioral manifestations Neurocognitive disorders Neurologic manifestations Physiological effects of drugs Signs and symptoms

How to take part

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

  1. The places running it

    4 sites. 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

  • Laval University

    RECRUITING

    Québec, Quebec, G1V 0A6, Canada

  • London Health Sciences

    ACTIVE_NOT_RECRUITING

    London, Ontario, N6A 5A5, Canada

  • Royal Columbian Hospital

    ACTIVE_NOT_RECRUITING

    Vancouver, British Columbia, V3L 0A2, Canada

  • St. Michael's Hospital

    NOT_YET_RECRUITING

    Toronto, Ontario, M5B 1W8, Canada

  • St. Paul's Hospital

    RECRUITING

    Vancouver, British Columbia, V6Z 1Y6, Canada

  • Sunnybrook Health Sciences Centre

    RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • Toronto General Hospital

    ACTIVE_NOT_RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

  • University of Saskatchewan

    ACTIVE_NOT_RECRUITING

    Saskatoon, Saskatchewan, S7N 0W8, Canada

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