Efficiency of Donepezil in Elderly Patients for Prevention of POCD Dysfunction

RenJi Hospital360 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

360

Conditions

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

Interventions

DonepezilDRUG

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

PlaceboDRUG

Placebo, 1 pill/ day for 7 days Po, was administrated from the day before surgery.

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The incidence of POCD after the surgery.

Time frame: up to 7 days

Secondary Outcomes

The incidence of postoperative delirium after surgery.

Time frame: 1 to 7 days after surgery

POCD incidence one month, six months and one year after surgery.

Time frame: one month, six months and one year after surgery