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Efficiency of Donepezil in Elderly Patients for Prevention of POCD Dysfunction

NCT ID: NCT04423276

Last Updated: 2020-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-14

Study Completion Date

2022-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Donepezil

Group Type EXPERIMENTAL

Donepezil

Intervention Type DRUG

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

Interventions

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Donepezil

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

OTHER

Sponsor Role collaborator

Tenth People's Hospital of Tongji Univeristy

UNKNOWN

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Diansan Su

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology Renji Hospital

Locations

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Renji Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Diansan Su, M.D., Ph.D.

Role: CONTACT

Phone: +8618616514088

Email: [email protected]

Facility Contacts

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Diansan Su

Role: primary

References

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Zhu H, Cong L, Chen Y, Chen S, Chen L, Huang Z, Zhou J, Xiao J, Huang Y, Su D. Efficiency of donepezil in elderly patients undergoing orthopaedic surgery due to underlying post-operative cognitive dysfunction: study protocol for a multicentre randomised controlled trial. Trials. 2021 Oct 9;22(1):688. doi: 10.1186/s13063-021-05648-0.

Reference Type DERIVED
PMID: 34627332 (View on PubMed)

Other Identifiers

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DNPQ20200523

Identifier Type: -

Identifier Source: org_study_id