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Sleep drug may shield elderly brains from Post-Surgery confusion

NCT ID NCT07695285

Disease control Sponsor: Beijing Tiantan 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Last updated Jul 15, 2026 · Updated 2 times

Summary

This study tests whether lemborexant, a sleep medication, can reduce postoperative delirium—a state of confusion and disorientation—in patients aged 60 and older after elective surgery under general anesthesia. Participants receive either lemborexant or a placebo before and after surgery. The main goal is to see if the drug lowers the rate of delirium within five days after the operation, with a secondary focus on sleep quality.

What this could mean

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

Active substance
Lemborexant
What this could lead to
If it works, this could offer a way to prevent postoperative delirium in elderly patients, potentially improving recovery and reducing hospital stays.
What could go wrong
This is a Phase 2 trial, so results are still uncertain. The drug may not reduce delirium, and side effects like daytime sleepiness or dizziness could occur.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 992 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

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: * Age ≥60 years old; * ASA classification I to III; * Patients undergoing elective surgery; * Sign the informed consent form. Exclusion Criteria: * Tracheal intubation is expected to be retained after the operation; * Previous history of alcohol or drug abuse; * Severe abnormalities in liver and kidney functions; * Long-term use of sedative-hypnotic drugs; * Severe sleep apnea and COPD; * Inability to cooperate in mental state; * Craniocerebral surgery * Pregnant and lactating patients; * Use drugs that affect orexin metabolism.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

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