Sleep hormone melatonin tested to stop Post-Surgery confusion in seniors
NCT ID NCT04335968
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.
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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
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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 Hide 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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Other studies related to the condition(s) this trial covers.
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