Could a common sedative shield aging brains from Post-Surgery delirium?

NCT ID NCT05168280

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This trial tests whether giving the sedative dexmedetomidine during brain surgery can prevent postoperative delirium in patients aged 65 and older. Delirium, a state of sudden confusion and altered awareness, affects up to 22% of people after neurological procedures. Researchers will compare patients who receive the drug with those who get a placebo, and they will check for delirium using standard assessment tools in the days 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, a sedative drug given through an IV during surgery
What this could lead to
If it works, this could offer a simple way to protect older patients from confusion and memory problems after brain surgery.
What could go wrong
This is an early-stage trial, and the drug may not reduce delirium in this specific group. Dexmedetomidine can also cause low blood pressure or a slow heart rate.

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

420 people

The number who actually took part.

Started

Jul 2022

Finished

Jun 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

65 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: * Patients undergoing selective craniotomy. * Age ≥65 years. * Obtain written informed consent. Exclusion Criteria: * Operation time less than 2 hours. * Refusal to provide written informed consent. * Cognitive impairment before surgery(mini-mental state examination, MMSE ≤ 26 or Montreal Cognitive Assessment, MoCA≤22). * Allergic to the study drug. * Body mass index ≤18 or ≥ 30 kg/m2. * History of psychotropic drugs, anticholinergic drugs, antihistamine drug and dopaminergic drugs. * History of traumatic brain injury or neurosurgery. * Severe bradycardia (heart rate less than 40 beats per minute), sick sinus syndrome or second-to-third degree atrioventricular block. * Severe liver dysfunction (Child-Pugh grade C) or renal failure (requiring kidney replacement therapy). * The functional neurosurgery.

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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.

Contacts and locations

Locations

  • Beijing Tian Tan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100070, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, China

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