The effects of melatonin versus placebo on post-operative delirium (POD) in hip fracture patients – a randomized double-blind trial
- Conditions
- Melatonin, delirium, prevention, hipfracturesMelatonine, delirium, preventie, heupfracturen
- Registration Number
- NL-OMON23033
- Lead Sponsor
- S.E. de Rooij / Academic Medical Centre AmsterdamAcademic Medical CenterMeibergdreef 91105 AZ AmsterdamThe NetherlandsTel. (31)205665991Fax (31)205669325
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 175
Inclusion Criteria
1. Age: 65 yrs or older
2. Unplanned surgical repair of hip or femoral fracture
Exclusion Criteria
1. Age: under 65 yrs
2. Delirium:pre-operative
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint will be the occurrence of POD diagnosed with the Confusion Assessement Method (CAM-score) within 5 days after surgery.
- Secondary Outcome Measures
Name Time Method 1. Whether visual assessment of SPECT scans may reveal perfusion abnormalities in frontal or parietal cerebral perfusion abnormalities in patients with and without POD using placebo and in (non)-delirious patients using melatonin. <br /><br>2. Differences in plasma melatonin concentrations in delirious and non-delirious patients using placebo and in patients using melatonin <br /><br>3. Severity and duration of POD in placebo and melatonin group <br /><br>4. Both hospital and post-discharge complications in (non) delirious patients using placebo and melatonin<br>