Efficiency of Donepezil in Elderly Patients for Prevention of POCD Dysfunction

Total Knee Arthroplasty Clinical Trial

Official title:

Efficiency of Donepezil in Elderly Patients Undergoing Orthopedic Surgery Due to Underlying Postoperative Cognitive Dysfunction, a Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04423276
• Other study ID #: DNPQ20200523
• Status: Recruiting
• Phase: Phase 4
• Start date: June 14, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: December 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: 360
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

1. Elder than 60 years old

2. Speak Chinese Mandarin

3. Scheduled to undergo hip or knee replacement surgery and lumbar spine surgery

4. The operation time is more than 2 hours.

5. Signed the informed consent

6. American Society of Anesthesiologists (ASA) classification I-II

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. Patients with tumors or infections

5. Unwillingness to comply with the protocol or procedures

6. Can not communicate normally in Mandarin Chinese

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

8. Existing gastrointestinal ulcer

9. Existing urinary incontinence

10. Existing asthma or chronic obstructive pulmonary disease

11. Postoperative admission to ICU

12. Allergic to donepezil

Related Conditions & MeSH terms

• Fracture of Head of Femur Articular Displaced
• Protrusion of Intervertebral Disc
• Total Knee Arthroplasty

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	Renji Hospital	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
RenJi Hospital	Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Tenth People's Hospital of Tongji Univeristy

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of POCD after the surgery.		up to 7 days
Secondary	The incidence of postoperative delirium after surgery.		1 to 7 days after surgery
Secondary	POCD incidence one month, six months and one year after surgery.		one month, six months and one year after surgery