Treatment with 3 mg melatonin daily will reduce the incidence of postoperative delirium in patients with hipfractures over 65 years of age.
ID
Bron
Verkorte titel
Aandoening
Melatonin, delirium, prevention, hipfractures
Melatonine, delirium, preventie, heupfracturen
Ondersteuning
Academic Medical Center
Meibergdreef 9
1105 AZ Amsterdam
The Netherlands
Tel. (31)205665991
Fax (31)205669325
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primary endpoint will be the occurrence of POD diagnosed with the Confusion Assessement Method (CAM-score) within 5 days after surgery.
Doel van het onderzoek
Treatment with 3 mg melatonin daily will reduce the incidence of postoperative delirium in patients with hipfractures over 65 years of age.
Onderzoeksopzet
Patiente will be included before surgical treatment for hip- or femoral fracture.
Melatonin will be given once daily for day 1 untill day 5 postoperative.
We will measure melatonin bloodlevels on day 2 and day 5 postoperative.
Onderzoeksproduct en/of interventie
After informed consent and after surgical repair of the hip fracture, patients are randomized to receive melatonin 3 mg or placebo in the evening with a maximum of 5 days. After reaching g the primary endpoint, ie delirium, the patient will start with haloperidol and treatment with melatonin or placebo will be ended.
Algemeen / deelnemers
Meibergdreef 9
H.E. Oosten, van
Dept. of Internal Medicine, F4-159
section of Geriatric Medicine
Amsterdam 1105 AZ
The Netherlands
(31)205665991
hvanoosten@gmail.com
Wetenschappers
Meibergdreef 9
H.E. Oosten, van
Dept. of Internal Medicine, F4-159
section of Geriatric Medicine
Amsterdam 1105 AZ
The Netherlands
(31)205665991
hvanoosten@gmail.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Age: 65 yrs or older
2. Unplanned surgical repair of hip or femoral fracture
3. Patients must be willing and medically able to receive therapy according to the protocol for the duration of the study
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Age: under 65 yrs
2. Delirium:pre-operative
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