Melatonin for Prevention of Postoperative Delirium After Lower Limb Fracture Surgery in Elderly Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

357

Participants

Timeline

Start Date

January 23, 2021

Primary Completion Date

April 18, 2025

Study Completion Date

April 18, 2025

Conditions
Orthopedic Surgery
Interventions
DRUG

Melatonin 4 mg

melatonin 4mg per os every night, starting the evening before surgery (or 2 hours before emergency surgery) and until day 5 after surgery.

DRUG

Placebo oral tablet

placebo of this drug with the same schedule, during the same period of time.

Trial Locations (1)

93390

hôpital Beaujon, Clichy-sous-Bois

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT04335968 - Melatonin for Prevention of Postoperative Delirium After Lower Limb Fracture Surgery in Elderly Patients | Biotech Hunter | Biotech Hunter