Efficiency of Donepezil in Elderly Patients for Prevention of POCD Dysfunction

Phase 4

• Conditions: Total Knee Arthroplasty; Fracture of Head of Femur Articular Displaced; Protrusion of Intervertebral Disc
• Interventions: Drug: Placebo; Drug: Donepezil

• Registration Number: NCT04423276
• Lead Sponsor: RenJi Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-06
• Study First Submitted QC: 2020-06-08
• Study First Posted: 2020-06-09
• Study Start: 2020-06-14
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-28
• Last Update Posted: 2020-12-29
• Primary Completion: 2021-12-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	-
Donepezil	Donepezil	-

Primary Outcome Measures

Name	Time	Method
The incidence of POCD after the surgery.	up to 7 days

Secondary Outcome Measures

Name	Time	Method
The incidence of postoperative delirium after surgery.	1 to 7 days after surgery
POCD incidence one month, six months and one year after surgery.	one month, six months and one year after surgery

Trial Locations

Locations (1)

Renji Hospital; 🇨🇳 Shanghai, Shanghai, China