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Sleep hormone melatonin tested to stop Post-Surgery confusion in seniors

NCT ID NCT04335968

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested whether giving melatonin, a natural sleep hormone, could prevent delirium (sudden confusion) in elderly patients after leg fracture surgery. Delirium affects up to 40% of older adults after major surgery and can lead to longer hospital stays and loss of independence. The trial enrolled 357 patients aged 70 and older, giving them either 4 mg of melatonin or a placebo each night from before surgery until five days after.

What this could mean

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

Active substance
Melatonin
What this could lead to
If it works, this could give doctors a simple, safe way to prevent confusion after surgery in older adults.
What could go wrong
The trial is completed but results are not yet widely confirmed. Melatonin may not reduce delirium in all patients, and individual responses can vary.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

357 people

The number who actually took part.

Started

Jan 2021

Finished

Apr 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

70 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: * Demographic criteria: patient 70 years old or older * Diagnostic criteria: isolated fracture of a lower limb * Proximal femoral fractures: head, cervical, or trochanteric fractures * Periprosthetic hip fracture * Femoral shaft fracture * Distal femoral fractures: supracondylar or condylar * Periprosthetic knee fracture * Tibial plateau fracture * Treatments/strategies/procedures: scheduled orthopedic surgery (osteosynthesis or arthroplasty) * proxy or care giver knowing baseline cognitive status of the patient present or reachable by phone for an interview Exclusion Criteria: * Patient already taking Melatonin * Contraindications and precaution for use of Melatonin administration: * Hypersensitivity to the active substance or to any of the excipients of Circadin© * Liver failure (presence of some of the following clinical and biological symptoms: icterus, asterixis, ascites, known esophageal varices, total bilirubin \>20 micromol/L, FV \<70%), * Cirrhosis (known histological liver fibrosis) * Renal failure with clearance \<30 ml/min O Autoimmune disease O Hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome * Patients taking fluvoxamine, 5- or 8-methoxypsoralen, cimetidine, oestrogenotherapy, quinolones, carbamazepine, rifampicin * Other concomitant trauma than lower limb fracture(s) * Surgery scheduled in more than 5 days * Patient under mechanical ventilation * Patient refusing to participate * Patient not talking / understanding French (delirium assessment impossible) * Patient already participating to another interventional study * No signed informed consent, * No affiliation to a social security regime Secondary Exclusion Criteria: Secondary exclusion (before randomization): diagnosis of delirium at the CAM assessment at inclusion, or creatinin clearance \<30 ml / min and /or biological signs of hepatocellular insufficiency (bilirubin\> 20 umol/l and factor V \<70%) if samples not available during the anesthesiologist consultation and so performed after inclusion.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • hôpital Beaujon

    Clichy-sous-Bois, 93390, France

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