Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could a sleep drug shield older hearts from post-surgery delirium?

NCT ID NCT02856594

Disease control Sponsor: Massachusetts General 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This trial tests whether giving dexmedetomidine, a sedative, at night can help older adults sleep and reduce the risk of delirium after cardiac surgery. Participants are 60 or older and scheduled for heart surgery with a planned ICU stay. Half receive the drug, half receive a placebo, and researchers track delirium, coma-free days, and survival over time.

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 given by IV at night to promote sleep
What this could lead to
If effective, this could offer a simple way to reduce delirium and improve recovery in older adults after heart surgery.
What could go wrong
The trial is in Phase 2/3, so results are not yet confirmed. Dexmedetomidine may cause side effects like low blood pressure or slow heart rate, and its benefit over placebo is uncertain.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

469 people

The number who actually took part.

Started

Mar 2017

Finished

Feb 2022

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

Accepted

You do not need to have the condition being studied to take part.

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: * Age ≥ 60 * Scheduled for a cardiac surgical procedure with planned post-operative admission to the CSICU for ≥ 24 hours * Scheduled same day surgical admission Exclusion Criteria: * Blind, deafness or the inability to speak English * Greater than 2 days of ICU admission in the month preceding the current surgical procedure * Renal and liver failure requiring dialysis or Child-Pugh score \> 5 * Follow-up difficulties (i.e. active substance abuse, psychotic disorder, homelessness) * Previous cardiac surgery within 1 year of surgical procedure * Allergy to dexmedetomidine * Chronic therapy with benzodiazepines and/or antipsychotics * Severe deficit due to structural or anoxic brain damage * Surgical procedure requiring total circulatory arrest Objective Drop Criteria * Scheduled for a second surgical procedure during hospital stay * Post-operative intubation \> 12 hours

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Anesthesia are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

Emergence Delirium sleep disorder

As listed by the trial registrant

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

Anesthesia Postoperative delirium Sleep

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

More trials for these conditions

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