Efficiency of Donepezil in Elderly Patients for Prevention of POCD Dysfunction

  • STATUS
    Recruiting
  • days left to enroll
    65
  • participants needed
    360
  • sponsor
    RenJi Hospital
Updated on 28 January 2021
anesthesia
total knee replacement

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.

Details
Condition Repair of knee joint, Knee Replacement, Knee Surgery, Slipped disc, Knee Surgery, Knee Replacement, Fracture of Head of Femur Articular Displaced, total knee replacement, total knee arthroplasty, knee replacements, knee arthroplasty
Treatment Placebo, donepezil
Clinical Study IdentifierNCT04423276
SponsorRenJi Hospital
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Elder than 60 years old
Speak Chinese Mandarin
Scheduled to undergo hip or knee replacement surgery and lumbar spine surgery
The operation time is more than 2 hours
Signed the informed consent
American Society of Anesthesiologists (ASA) classification I-II

Exclusion Criteria

Existing cerebral disease, or have a history of neurological and psychiatric diseases including Alzheimer Disease, stroke, epilepsy and psychosis
Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24
Several audition or vision disorder
Patients with tumors or infections
Unwillingness to comply with the protocol or procedures
Can not communicate normally in Mandarin Chinese
Existing bradycardiac arrhythmia (Heart rate <60 bpm for any reasons)
Existing gastrointestinal ulcer
Existing urinary incontinence
Existing asthma or chronic obstructive pulmonary disease
Postoperative admission to ICU
Allergic to donepezil
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