Delirium Clinical Trial
Official title:
Supporting the Health of Adults Undergoing Orthopedic Surgery During the Recovery Period
Delirium (acute confusion) is a highly prevalent condition among hospitalized elders with
substantial morbidity within the hospital and beyond. Particular patient populations are at
high risk for poor outcomes after an episode of delirium. Patients with hip and other long
bone fractures are at increased risk of developing delirium (acute confusion) which impedes
functional recovery. This is a pilot study to test the tolerability and efficacy of
donepezil, a cholinesterase inhibitor medication used commonly in persons with dementia, for
the prevention of new or worsening delirium in aged hip and other long-bone fracture
patients. Additional purposes involve gathering a small amount of patients' serum to better
understand the pathophysiology of delirium in this population.
The purposes of this pilot study are to determine: 1) the safety and tolerability a
cholinesterase inhibitor medication) in aged hip and long bone fracture patients, 2) To
obtain estimates of subject accrual and preliminary estimates of effect size on the
development of new delirium symptoms to allow for planning of a larger, definitive trial, 3)
To better understand the underlying causes of delirium by examining whether a measure of
blood anticholinergic activity relates to the incidence and persistence of delirium
symptoms, and 4) To explore the interaction between anticholinergic activity, donepezil
therapy, and delirium symptoms.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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