Donepezil Attenuate Postoperative Cognitive Dysfunction

Rheumatoid Arthritis Clinical Trial

— DAPOCD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02927522
• Other study ID #: RJ20161003
• Status: Recruiting
• Phase: Phase 3
• Start date: September 1, 2018
• Est. completion date: December 2021

Study information

• Verified date: January 2020
• Source: RenJi Hospital
• Contact: Diansan Su, M.D., Ph.D.
• Phone: +8618616514088
• Email: diansansu[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Femoral Head Necrosis
• Necrosis
• Osteoarthritis
• Rheumatoid Arthritis

Intervention

Drug:
• Donepezil
Donepezil a cholinesterase inhibitor, 5mg(1 pill)/ day for 7 days Po, was administrated from the day before surgery.
• Placebo
Placebo, 1 pill/ day for 7 days Po, was administrated from the day before surgery.

Locations

Country	Name	City	State
China	Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
RenJi Hospital	Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of POCD 7 days(or before leaving hospital ) after surgery		7 days after surgery or before leaving hospital
Primary	The incidence of postoperative delirium after surgery		1 to 7 days after surgery
Secondary	POCD incidence 1 months after surgery		1 months after surgery