Donepezil Attenuate Postoperative Cognitive Dysfunction

Study Overview
=================
Brief Summary
-----------------
Postoperative cognitive dysfunction (POCD) occurs mainly in aged patients. POCD may increase the mortality and morbidity. However, the mechanism of POCD is not clear yet and no effective therapy method was proved. According to our previous study, the central cholinergic system impaired by the anesthesia and surgery play a very important role in the POCD and donepezil an acetylcholinesterase inhibitor can prevent the POCD after isoflurane anesthesia in aged mice. Donepezil is a commercial medicine used for the Alzheimer Disease, which is tolerable and has minimal adverse events. In present study a multi-center randomized case control study was conducted and we hypothesized that donepezil attenuate the POCD.

Official Title
-----------------
Donepezil Attenuate Postoperative Cognitive Dysfunction in Aged Patients- A Multi-center, Case Control, Randomized Clinical Trail

Conditions
-----------------
Osteoarthritis, Femoral Head Necrosis, Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Donepezil
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elder than 60 years old Speak Chinese Mandarin Those who will undergo knee or hip replacement Signed the inform consent American Society of Anesthesiologists classification I to III Exclusion Criteria: Existing cerebral disease, or have a history of neurological and psychiatric diseases including Alzheimer Disease, stroke, epilepsy and psychosis; existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24; several audition or vision disorder; unwillingness to comply with the protocol or procedures. Can not communicated with Chinese Mandarin Existing bradycardiac arrhythmia（Heart rate <60 bpm for any reasons） Existing gastrointestinal ulcer Existing urinary incontinence Existing asthma or chronic obstructive pulmonary disease Allegory to Donepezil

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Placebo was administrated | Drug: Placebo<br>* Placebo, 1 pill/ day for 7 days Po, was administrated from the day before surgery.<br>|
| Experimental: Donepezil<br>Donepezil (5mg/ day for 7 days) was administrated | Drug: Donepezil<br>* Donepezil a cholinesterase inhibitor, 5mg(1 pill)/ day for 7 days Po, was administrated from the day before surgery.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of POCD 7 days(or before leaving hospital ) after surgery |  | 7 days after surgery or before leaving hospital | 
| The incidence of postoperative delirium after surgery |  | 1 to 7 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POCD incidence 1 months after surgery |  | 1 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative Cognitive Dysfunction, Donepezil, Hip replacement, Knee replacement, Postoperative delirium