Donepezil in Preventing Delirium in Hospitalized Elderly

Phase 4

Completed

• Conditions: Postoperative Complications; Delirium

• Registration Number: NCT00182884
• Lead Sponsor: Indiana University Health

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-16
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2008-02
• Last Update Submitted: 2008-02-28
• Last Update Posted: 2008-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative cumulative incident cases of delirium, as defined by the Confusion Assessment Method (CAM) administered at baseline prior to surgery and daily until discharge
delirium severity as measured by the Memorial Delirium Assessment Scale (MDAS)

Secondary Outcome Measures

Name	Time	Method
Cognitive status as measured by the Mini Mental Status Exam (MMSE)
behavioral status using the Rating Scale for Aggressive Behavior in the Elderly (RAGE)
length of stay in hospital postoperatively
discharge site
adverse effects
use of psychotropic medications

Trial Locations

Locations (1)

Methodist Hospital, Clarian Health Partners; 🇺🇸 Indianapolis, Indiana, United States