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Simple painkiller may stop Post-Surgery brain fog in seniors

NCT ID NCT04093219

Prevention Sponsor: Beth Israel Deaconess Medical Center 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether giving IV acetaminophen (Tylenol) every 6 hours during and after heart surgery could prevent delirium—sudden confusion—in patients aged 60 and older. Delirium is common after heart surgery and can lead to longer hospital stays and other problems. The trial enrolled 900 older adults having bypass or valve surgery and compared the drug to a placebo (saline). The goal was to see if this simple, low-cost approach could reduce the risk of postoperative delirium.

What this could mean

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

Active substance
IV acetaminophen (Tylenol)
What this could lead to
If it works, this could provide a simple, safe way to prevent delirium after heart surgery in older patients.
What could go wrong
This trial is completed but results may not show a clear benefit; delirium is complex and a single drug may not be enough. Also, the study only included older adults having specific heart surgeries.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

900 people

The number who actually took part.

Started

Aug 2020

Finished

Apr 2026

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: 1. ≥ 60 years of age 2. Patients undergoing cardiac surgery \[coronary artery bypass grafting (CABG) with or without valve, isolated valve surgery\] requiring cardiopulmonary bypass Exclusion Criteria: 1. Pre-operative left ventricular ejection fraction (LVEF) \< than 30% 2. Emergent procedures 3. Isolated aortic surgery 4. Liver dysfunction (liver enzymes \> 3 times the baseline, all patients will have a baseline liver function test information), history and exam suggestive of jaundice 5. Hypersensitivity to the study drugs 6. Active (in the past year) history of alcohol abuse (≥5 drinks per day for men or ≥ 4 drinks per day for women) 7. Any history of alcohol withdrawal or delirium tremens 8. Delirium at baseline 9. Non-English speaking 10. Prisoners 11. Physician Refusal 12. COVID-19 Positive, symptomatic 13. Co-enrollment with non-approved interventional trial

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Conditions

The condition(s) this trial relates to.

coronary artery disorder delirium

As listed by the trial registrant

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

Coronary artery disease Delirium Delirium in old age

Contacts and locations

Locations

  • Albert Einstein College of Medicine- Montefiore

    The Bronx, New York, 10467, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Columbia University Irving Medical Center

    New York, New York, 10032, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of California Irvine

    Irvine, California, 92697, United States

  • University of California Los Angeles

    Los Angeles, California, 90095, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • Yale University/Yale New Haven Hospital

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.