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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02927522
Date of registration: 05/10/2016
Prospective Registration: Yes
Primary sponsor: RenJi Hospital
Public title: Donepezil Attenuate Postoperative Cognitive Dysfunction DAPOCD
Scientific title: Donepezil Attenuate Postoperative Cognitive Dysfunction in Aged Patients- A Multi-center, Case Control, Randomized Clinical Trail
Date of first enrolment: September 1, 2018
Target sample size: 550
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02927522
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 3
Countries of recruitment
China
Contacts
Name:     Diansan Su, M.D., Ph.D.
Address: 
Telephone:
Email:
Affiliation:  RenJi Hospital
Name:     Diansan Su, M.D., Ph.D.
Address: 
Telephone: +8618616514088
Email: diansansu@yahoo.com
Affiliation: 
Name:     Xiaoxue Hu
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Elder than 60 years old

2. Speak Chinese Mandarin

3. Those who will undergo knee or hip replacement

4. Signed the inform consent

5. American Society of Anesthesiologists classification I to III

Exclusion Criteria:

1. Existing cerebral disease, or have a history of neurological and psychiatric diseases
including Alzheimer Disease, stroke, epilepsy and psychosis;

2. existing cognitive impairment as evidenced by Mini-Mental State Examination scores
below 24;

3. several audition or vision disorder;

4. unwillingness to comply with the protocol or procedures.

5. Can not communicated with Chinese Mandarin

6. Existing bradycardiac arrhythmia(Heart rate <60 bpm for any reasons)

7. Existing gastrointestinal ulcer

8. Existing urinary incontinence

9. Existing asthma or chronic obstructive pulmonary disease

10. Allegory to Donepezil



Age minimum: 60 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Femoral Head Necrosis
Osteoarthritis
Intervention(s)
Drug: Placebo
Drug: Donepezil
Primary Outcome(s)
The incidence of POCD 7 days(or before leaving hospital ) after surgery [Time Frame: 7 days after surgery or before leaving hospital]
The incidence of postoperative delirium after surgery [Time Frame: 1 to 7 days after surgery]
Secondary Outcome(s)
POCD incidence 1 months after surgery [Time Frame: 1 months after surgery]
Secondary ID(s)
RJ20161003
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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