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Sleep hormone may ward off Post-Surgery delirium in seniors

NCT ID NCT03785158

Prevention Sponsor: McMaster University 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether giving melatonin, a natural sleep hormone, could prevent delirium (sudden confusion) in elderly patients after major non-cardiac surgery. Researchers enrolled 88 patients aged 65 and older across multiple hospitals. The goal was to see if a larger trial is possible, not yet to prove melatonin works.

What this could mean

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

Active substance
Melatonin (liquid supplement)
What this could lead to
If it works, this could point toward a simple, low-cost way to prevent delirium in older patients after major surgery.
What could go wrong
This was only a small pilot study testing feasibility, not effectiveness. The results may not show a clear benefit, and larger trials are needed.

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

88 people

The number who actually took part.

Started

Sep 2021

Finished

Jul 2025

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: * Age \>65 years * having a major non-cardiac surgery (which involve major vascular, thoracic, orthopedic, gynecological, otolaryngeal, general and gastrointestinal surgeries) with an expected hospital stay of 2 days or more, and * ability to provide informed consent Exclusion Criteria: * active delirium or dementia * ongoing melatonin treatment * unable to take oral medications * planned postoperative ventilation * previous study participation * allergy to melatonin * hepatic impairment defined as alanine aminotransferase greater than 500 IU/L * previous liver transplant or liver cirrhosis of Child-Pugh classes B and C * not willing to participate * language barrier

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Conditions

The condition(s) this trial relates to.

delirium Emergence Delirium insomnia Sleep Deprivation

As listed by the trial registrant

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

Major non-cardiac surgery Post operative delirium

Contacts and locations

Locations

  • Hamilton Health Sciences-Juravinski Hospital Location

    Hamilton, Ontario, L8V 1C3, Canada

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6, Canada

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Other studies related to the condition(s) this trial covers.