Donepezil in Preventing Delirium in Hospitalized Elderly

Indiana University Health

Status and phase

Completed

Phase 4

Conditions

Postoperative Complications

Delirium

Treatments

Drug: Donepezil

Study type

Interventional

Funder types

Other

Identifiers

NCT00182884

VFR-161

IA0079

Details and patient eligibility

About

The purpose of this study is to explore the efficacy of a perioperative daily dose of Donepezil (a cholinergic enhancer) in reducing the incidence and severity of delirium.

Full description

Delirium is confusion or a sudden change in alertness which may happen after hip repair surgery. Up to 65% of elderly undergoing surgical repair of hip fracture experience post-operative delirium. These individuals often stay in the hospital longer, have more complications, and are more likely to die. Early studies suggest that delirium could be prevented by correcting the central cholinergic deficit that is associated with delirium. Donepezil is currently being used to treat memory loss in patients with Alzheimer's disease.

This study will recruit 30 adults aged 65 or older who are undergoing hip fracture surgery. Participants will be randomized to receive either Donepezil or a matching placebo within 24 hours prior to surgery and for 4 days after the surgery.

All material to be collected will be from interviews, questionnaires, and medical chart review at baseline and daily for the entire hospital stay. The Confusion Assessment Method (CAM) and Memorial Delirium Assessment Scale (MDAS) will be used to evaluate the effect of Donepezil on delirium incidence and severity. Other assessments include cognitive deficit, length of hospitalization, discharge site, adverse effects, and psychotropic medications.

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Community-dwelling individuals aged 65 or older
Admitted to Methodist Hospital for surgical repair of hip fracture
No evidence of delirium at admission to hospital
MMSE total score below 24 points after adjustment for education and age
Consent to participate in the study

Exclusion criteria

Severely demented as defined by MMSE score below 10
Metastatic cancer or other comorbid illnesses likely to reduce life expectancy to under 6 months
Multiple trauma or pathological fractures
Aphasic, legally blind, or deaf
Use of Donepezil or other cholinesterase inhibitors within one month prior to surgery
Allergy to Donepezil