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One dose during surgery may protect sleep after lung operations

NCT ID NCT07794982

Symptom relief Sponsor: Jingsheng Lou 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 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.
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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial tests whether giving a single dose of sodium oxybate during lung surgery helps older adults sleep better the first night after the operation. Researchers will compare sleep quality, measured by a questionnaire and a wrist monitor, between patients who receive the drug and those who get a placebo. The study includes 360 adults aged 65 and older undergoing thoracoscopic lung surgery. The goal is to see if this simple addition to anesthesia can reduce sleep disturbance and improve recovery.

What this could mean

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

Active substance
sodium oxybate
What this could lead to
If it works, a single dose given during surgery could help older adults sleep better after lung operations, potentially speeding recovery and reducing discomfort.
What could go wrong
This is an early-stage trial, and the drug may not improve sleep or could cause side effects. Results from one center may not apply to all patients.

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

About 360 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

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

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 scheduled for elective VATS lobectomy or segmentectomy under general anesthesia, who provide written informed consent, with anticipated surgical duration \> 1 hour. * Age ≥ 65 years old. * American Society of Anesthesiologists (ASA) physical status Ⅰ-Ⅲ. * Baseline cognitive function: Mini-Mental State Examination (MMSE) score ≥ 17, adjusted for educational level. Exclusion Criteria: * History of chronic alcohol abuse or illicit substance use. * Surgical completion time at or after 20:00. * History of central nervous system diseases (epilepsy, Parkinson's disease, dementia, prior stroke) or prior neurosurgical procedures. * Post-operative unplanned intensive care unit (ICU) admission. * Regular pre-operative use of sodium oxybate, benzodiazepines or other potent central nervous system depressants, unless discontinued for at least 5 elimination half-lives before surgery.

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As listed by the trial registrant

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

Thoracic surgical procedures

How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • Chinese PLA General Hospital

    Beijing, 100853, China

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