- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04423276
Efficiency of Donepezil in Elderly Patients for Prevention of POCD Dysfunction
December 28, 2020 updated by: RenJi Hospital
Efficiency of Donepezil in Elderly Patients Undergoing Orthopedic Surgery Due to Underlying Postoperative Cognitive Dysfunction, a Multicenter Randomized Controlled Trial
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
360
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Diansan Su, M.D., Ph.D.
- Phone Number: +8618616514088
- Email: diansansu@yahoo.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200127
- Recruiting
- Renji Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Donepezil
|
Donepezil a cholinesterase inhibitor, 5mg(1 pill)/ day for 7 days Po, was administrated from the day before surgery.
|
PLACEBO_COMPARATOR: Control
|
Placebo, 1 pill/ day for 7 days Po, was administrated from the day before surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The incidence of POCD after the surgery.
Time Frame: up to 7 days
|
up to 7 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The incidence of postoperative delirium after surgery.
Time Frame: 1 to 7 days after surgery
|
1 to 7 days after surgery
|
POCD incidence one month, six months and one year after surgery.
Time Frame: one month, six months and one year after surgery
|
one month, six months and one year after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Diansan Su, Department of Anesthesiology Renji Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 14, 2020
Primary Completion (ANTICIPATED)
December 1, 2021
Study Completion (ANTICIPATED)
December 1, 2022
Study Registration Dates
First Submitted
June 6, 2020
First Submitted That Met QC Criteria
June 8, 2020
First Posted (ACTUAL)
June 9, 2020
Study Record Updates
Last Update Posted (ACTUAL)
December 29, 2020
Last Update Submitted That Met QC Criteria
December 28, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DNPQ20200523
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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