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A simple nasal spray might shield the brain after heart surgery

NCT ID NCT06619912

Prevention Sponsor: Xijing 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 05, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This trial tests whether a sedative nasal spray, given the night before and just before cardiac surgery, can reduce the chance of postoperative delirium—a state of confusion that can complicate recovery. The idea is that improving sleep before surgery may protect the brain. About 686 adults undergoing heart surgery with a heart-lung machine will be randomly assigned to receive either the active spray or a placebo. Researchers will then monitor for delirium during the first week after surgery.

What this could mean

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

Active substance
Dexmedetomidine nasal spray
What this could lead to
If effective, this could offer a simple, non-invasive way to prevent delirium after cardiac surgery, potentially improving recovery and reducing complications.
What could go wrong
The trial is still in progress, and results are not yet known. The drug may not reduce delirium as hoped, and there are risks like low heart rate or other side effects.

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

686 people

The number who actually took part.

Started

Mar 2025

Finished

Sep 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

18 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. Aged 18 years or older. 2. Cardiac surgery with cardiopulmonary bypass. 3. Ability to provide consent. Exclusion Criteria: 1. Preoperative schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, history of neurosurgery, or Mini-mental State Examination(MMSE) score: illiteracy\<17, primary school level\<20, high school level \<24. 2. Patients with sick sinus syndrome, severe sinus bradycardia (heart rate\<50 beats/minute), grade II or above atrioventricular block, and no pacemaker implanted. 3. Unable to communicate due to coma, severe dementia, or language barriers prior to surgery. 4. Patients with severe liver dysfunction (Child Pugh C grade), renal dysfunction (preoperative dialysis), ASA grade V or expected survival ≤ 24 hours. 5. Heart transplant surgery 6. Surgery for congenital heart disease. 7. Deep hypothermic circulatory arrest surgery. 8. Already enrolled in other study patients. 9. Refuse to participate.

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Conditions

The condition(s) this trial relates to.

Emergence Delirium

As listed by the trial registrant

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

Postoperative delirium Preoperative sleep disorder

Contacts and locations

Locations

  • Xijing Hospital

    Xi'an, Shaanxi, 710032, China

More trials for these conditions

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