DAPOCD: Donepezil Attenuate Postoperative Cognitive Dysfunction

Sponsor

RenJi Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02927522

Collaborator

Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine (Other)

550

Enrollment

Location

Arms

Anticipated Duration (Months)

14.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis Femoral Head Necrosis Rheumatoid Arthritis	Drug: Donepezil Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

550 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 1, 2018

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control Placebo was administrated	Drug: Placebo Placebo, 1 pill/ day for 7 days Po, was administrated from the day before surgery.
Experimental: Donepezil Donepezil (5mg/ day for 7 days) was administrated	Drug: Donepezil Donepezil a cholinesterase inhibitor, 5mg(1 pill)/ day for 7 days Po, was administrated from the day before surgery.

Arm

Intervention/Treatment

Placebo Comparator: Control

Placebo was administrated

Drug: Placebo

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

Experimental: Donepezil

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

Drug: Donepezil

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

Outcome Measures

Primary Outcome Measures

The incidence of POCD 7 days(or before leaving hospital ) after surgery [7 days after surgery or before leaving hospital]
The incidence of postoperative delirium after surgery [1 to 7 days after surgery]

Secondary Outcome Measures

POCD incidence 1 months after surgery [1 months after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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