Efficiency of Donepezil in Elderly Patients for Preventio... | NCT04423276

Studies
Efficiency of Donepezil in Elderly Patients for Prevention of POCD Dysfunction

NCT04423276

Sponsor

RenJi Hospital

Status

Unknown status

Last Update Posted

Dec 29, 2020Actual

Enrollment

360Estimated

Phase

Phase 4

Conditions

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

Interventions

Donepezil
Placebo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 14, 2020Actual

Primary Completion Date

Dec 1, 2021Estimated

Completion Date

Dec 1, 2022Estimated

First Submitted Date

Jun 6, 2020

First Submission Date that Met QC Criteria

Jun 8, 2020

First Posted Date

Jun 9, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 28, 2020

Last Update Posted Date

Dec 29, 2020Actual

Name	Class
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine	OTHER
Tenth People's Hospital of Tongji Univeristy	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

360Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Placebo Comparator		Drug: Placebo
Donepezil	Experimental		Drug: Donepezil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Donepezil	Drug	Donepezil a cholinesterase inhibitor, 5mg(1 pill)/ day for 7 days Po, was administrated from the day before surgery.	Donepezil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The incidence of POCD after the surgery.		up to 7 days

Secondary Outcomes

Measure	Description	Time Frame
The incidence of postoperative delirium after surgery.		1 to 7 days after surgery
POCD incidence one month, six months and one year after surgery.		one month, six months and one year after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Diansan Su, M.D., Ph.D.	Contact	+8618616514088		diansansu@yahoo.com

Overall Officials

Name	Affiliation	Role
Diansan Su	Department of Anesthesiology Renji Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Renji Hospital	Recruiting	Shanghai	Shanghai Municipality	200127	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34627332	Derived	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.

ID	Term
D007189	Indans
D007192	Indenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic