Donepezil in Preventing Delirium in Hospitalized Elderly

Delirium Clinical Trial

Official title:

Preventing Delirium in Hospitalized Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00182884
• Other study ID #: IA0079
• Secondary ID: VFR-161
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: February 28, 2008
• Start date: July 2004
• Est. completion date: April 2007

Study information

• Verified date: February 2008
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Delirium
• Postoperative Complications

Intervention

Drug:
• Donepezil

Locations

Country	Name	City	State
United States	Methodist Hospital, Clarian Health Partners	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University Health

Country where clinical trial is conducted

United States, 

References & Publications (6)

Barrett-Connor E. The economic and human costs of osteoporotic fracture. Am J Med. 1995 Feb 27;98(2A):3S-8S. Review. — View Citation

Cooper C, Campion G, Melton LJ 3rd. Hip fractures in the elderly: a world-wide projection. Osteoporos Int. 1992 Nov;2(6):285-9. — View Citation

Cummings SR, Rubin SM, Black D. The future of hip fractures in the United States. Numbers, costs, and potential effects of postmenopausal estrogen. Clin Orthop Relat Res. 1990 Mar;(252):163-6. — View Citation

Galanakis P, Bickel H, Gradinger R, Von Gumppenberg S, Förstl H. Acute confusional state in the elderly following hip surgery: incidence, risk factors and complications. Int J Geriatr Psychiatry. 2001 Apr;16(4):349-55. — View Citation

Gustafson Y, Berggren D, Brännström B, Bucht G, Norberg A, Hansson LI, Winblad B. Acute confusional states in elderly patients treated for femoral neck fracture. J Am Geriatr Soc. 1988 Jun;36(6):525-30. — View Citation

Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative cumulative incident cases of delirium, as defined by the Confusion Assessment Method (CAM) administered at baseline prior to surgery and daily until discharge
Primary	delirium severity as measured by the Memorial Delirium Assessment Scale (MDAS)
Secondary	Cognitive status as measured by the Mini Mental Status Exam (MMSE)
Secondary	behavioral status using the Rating Scale for Aggressive Behavior in the Elderly (RAGE)
Secondary	length of stay in hospital postoperatively
Secondary	discharge site
Secondary	adverse effects
Secondary	use of psychotropic medications