Status:
COMPLETED
Melatonin for Prevention of Postoperative Delirium After Lower Limb Fracture Surgery in Elderly Patients
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Orthopedic Surgery
Eligibility:
All Genders
70+ years
Phase:
PHASE3
Brief Summary
Postoperative delirium (POD) is one of the most frequent complications after surgery in elderly patients, affecting between 20 and 40% of patients older than 60 after major surgery. This complication ...
Detailed Description
Postoperative delirium (POD) is one of the most frequent complications after surgery in elderly patients, affecting between 20 and 40% of patients older than 60 after major surgery. This complication ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2025
Estimated Enrollment :
357 Patients enrolled
Trial Details
Trial ID
NCT04335968
Start Date
January 23 2021
End Date
April 18 2025
Last Update
September 8 2025
Active Locations (1)
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1
hôpital Beaujon
Clichy-sous-Bois, France, 93390