Efficiency of Donepezil in Elderly Patients for Prevention of POCD Dysfunction

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 4

Conditions: Fracture of Head of Femur Articular Displaced; Protrusion of Intervertebral Disc; Total Knee Arthroplasty

Treatments: Drug: Donepezil; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04423276

DNPQ20200523

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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360 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Treatment:

Drug: Placebo

Donepezil

Experimental group

Treatment:

Drug: Donepezil