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Sleep aid breakthrough? esketamine trial targets Post-Surgery insomnia in menopause

NCT ID NCT07315074

Symptom relief Sponsor: Zhuan Zhang Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 01, 2026 · Updated 2 times

Summary

This study tests whether a drug called esketamine can improve sleep after surgery in postmenopausal women, who often have trouble sleeping. About 164 women having leg fracture surgery will receive esketamine or a placebo during the operation. Researchers will check their sleep quality and measure body rhythms like melatonin and cortisol to see if esketamine helps restore normal sleep patterns.

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 164 people

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

Started

Mar 2026

Expected to finish

Dec 2026

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

45 years and older

Sex

Female participants only

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. American Society of Anesthesiologists (ASA) physical status I-III. 2. Aged ≥ 45 years. 3. Women with natural menopause (aged ≥ 45 years and postmenopause for more than 12 months without surgical or medical intervention) . 4. Scheduled to undergo elective lower-limb fracture surgery with an expected duration of more than 60 min under general anesthesia. 5. Body Mass Index (BMI) between 18 and 28 kg/m². Exclusion Criteria: 1. Presence of preoperative sleep-related disorders, such as obstructive sleep apnea or restless legs syndrome. 2. History of drug or alcohol abuse or dependence. 3. Known contraindications or allergies to esketamine or other anesthetic agents. 4. Use of psychotropic medications or sex hormones within the past 3 months. 5. Shift work or taking medications affecting melatonin. 6. Severe comorbid conditions, including but not limited to uncontrolled hypertension, coronary artery disease, cardiac insufficiency, pulmonary hypertension, intracranial hypertension or elevated intraocular pressure, hyperthyroidism, severe hepatic or renal dysfunction. 7. History of cerebral infarction, intracerebral hemorrhage, or residual central nervous system deficits. 8. Impairments of language, hearing, vision, or cognitive function that would prevent completion of questionnaires or cooperation with sleep monitoring. 9. Active oral pathologies. 10. Transfer to ICU postoperatively.

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Conditions

The condition(s) this trial relates to.

circadian rhythm sleep disorder

As listed by the trial registrant

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

Circadian rhythm Postoperative sleep disturbance

How to take part

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

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Jingjiang People's Hospital Affiliated to Yangzhou University, Yangzhou University

    RECRUITING

    Jingjiang, Jiangsu, 214500, China

  • The Affiliated Hospital of Yangzhou University, Yangzhou University

    RECRUITING

    Yangzhou, Jiangsu, 225012, China

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