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Nighttime sedative may cut delirium in elderly heart surgery patients

NCT ID NCT03624595

Symptom relief Sponsor: Dong-Xin Wang Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a low-dose sedative called dexmedetomidine at night can prevent delirium (sudden confusion) in older adults after heart surgery. The trial involved 504 patients aged 60-89 who had heart surgery with a heart-lung machine. The drug was infused overnight for up to 5 nights, and patients were checked for delirium twice daily. The goal was to see if this simple nighttime treatment could improve sleep, reduce confusion, and possibly boost long-term survival.

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 provide a simple way to reduce confusion and improve recovery in older adults after heart surgery.
What could go wrong
This is a completed trial, but results may not apply to all patients. The drug can cause low blood pressure or slow heart rate, and benefits may be modest.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

504 people

The number who actually took part.

Started

Apr 2019

Finished

May 2025

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 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. Age ≥60 years but \<90 years; 2. Scheduled to undergo cardiac surgery with cardiopulmonary bypass under general anesthesia; 3. Expected to stay in the intensive care unit (ICU) for at least 1 night after surgery. Exclusion Criteria: Patients who meet any of the following criteria will be excluded. 1. Refuse to participate in the study; 2. Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis; 3. Preoperative obstructive sleep apnea (previously diagnosed as obstructive sleep apnea, or the snoring, tiredness, observed apnea, high blood pressure-body mass index, age, neck circumference and gender \[STOP-Bang\] questionnaires ≥3); 4. Inability to communicate during the preoperative period because of coma, profound dementia or language barrier; 5. Preoperative sick sinus syndrome, severe sinus bradycardia (\< 50 beats per minute), or second-degree atrioventricular block or above without pacemaker; 6. Severe hepatic dysfunction (Child-Pugh class C); 7. Severe renal dysfunction (requirement of renal replacement therapy) before surgery; 8. Presence of delirium (diagnosed by the Confusion Assessment Method \[CAM\]/CAM for the Intensive Care Unit \[CAM-ICU\]); 9. Current treatment with dexmedetomidine or clonidine.

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Conditions

The condition(s) this trial relates to.

delirium

As listed by the trial registrant

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

Cardiac surgery Cardiopulmonary bypass Delirium Dexmedetomidine Survival

Contacts and locations

Locations

  • Beijing University First Hospital

    Beijing, Beijing Municipality, 100034, China

  • Fuwai Hospital of Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100037, China

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