Trial | NCT02927522  Report issue

Title

Donepezil Attenuate Postoperative Cognitive Dysfunction
Donepezil Attenuate Postoperative Cognitive Dysfunction in Aged Patients- A Multi-center, Case Control, Randomized Clinical Trail

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    donepezil ...

  • Study Participants

    550
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 Started
Sep 01
2018
Primary Completion
Dec 31
2021
Anticipated
Study Completion
Dec 31
2021
Anticipated
Last Update
Jan 30
2020

Drug Donepezil

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

Drug Placebo

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

Control Placebo Comparator

Placebo was administrated

Donepezil Experimental

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

Criteria 

Inclusion Criteria:

Elder than 60 years old
Speak Chinese Mandarin
Those who will undergo knee or hip replacement
Signed the inform consent
American Society of Anesthesiologists classification I to III

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;
unwillingness to comply with the protocol or procedures.
Can not communicated with Chinese Mandarin
Existing bradycardiac arrhythmia（Heart rate <60 bpm for any reasons）
Existing gastrointestinal ulcer
Existing urinary incontinence
Existing asthma or chronic obstructive pulmonary disease
Allegory to Donepezil
No Results Posted