Donepezil Attenuate Postoperative Cognitive Dysfunction (DAPOCD)

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 3

Conditions: Femoral Head Necrosis; Osteoarthritis; Rheumatoid Arthritis

Treatments: Drug: Donepezil; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02927522

RJ20161003

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: 550 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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550 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Placebo was administrated

Treatment:

Drug: Placebo

Donepezil

Experimental group

Description:

Donepezil (5mg/ day for 7 days) was administrated

Treatment:

Drug: Donepezil