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Sleep hormone melatonin may boost recovery after gallbladder surgery

NCT ID NCT07553143

Symptom relief Sponsor: Armed Forces Medical Institute Bangladesh 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether taking melatonin before gallbladder surgery helps patients recover better. Melatonin is a natural hormone that helps with sleep and may also reduce pain and anxiety. The trial will involve 84 adults in Bangladesh, comparing those who get melatonin to those who get a placebo. Researchers will measure recovery quality, sleep, pain, and nausea in the first day after surgery.

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 84 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Jun 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

18 to 60 years

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 18-60 years * American Society of Anesthesiologists (ASA) physical status I-II * Scheduled for elective laparoscopic cholecystectomy under general anesthesia * Able to understand and provide informed consent * Willing to participate in the study and complete follow-up assessments * Body mass index (BMI) 18-35 kg/m2 Exclusion Criteria: * Known allergy or hypersensitivity to melatonin or placebo component * Chronic use of opioids, sedatives, or hypnotics (regular use for ≥4 weeks prior to surgery) * Current use of beta-adrenergic receptor antagonists (beta-blockers) (suppress endogenous melatonin secretion via inhibition of pineal β₁-adrenergic receptors) * History of psychiatric disorders requiring ongoing pharmacological treatment * Pregnancy or lactation * Severe hepatic impairment (Child-Pugh class B or C), as melatonin undergoes extensive first-pass hepatic metabolism via CYP1A2 * Diagnosed obstructive sleep apnoea requiring continuous positive airway pressure * Diagnosed circadian rhythm disorder (e.g., delayed sleep phase disorder, advanced sleep phase disorder) requiring medical management * Use of exogenous melatonin supplements within 30 days prior to surgery * Inability to complete study questionnaires due to language barrier or cognitive impairment * History of substance abuse or dependence

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As listed by the trial registrant

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

Laparoscopic cholecystectomy Opioid consumption, postoperative Ponv in laparoscopic cholocystectomies Postoperative quality of recovery Postoperative sleep quality Preoperative anxiety

How to take part

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

  1. The places running it

    1 site. 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

  • Department of Anaesthesiology, Combined Military Hospital, Dhaka Cantonment,Dhaka

    Dhaka, Dhaka Division, 1206, Bangladesh

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