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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02927522 |
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Date of registration:
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05/10/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Donepezil Attenuate Postoperative Cognitive Dysfunction
DAPOCD |
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Scientific title:
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Donepezil Attenuate Postoperative Cognitive Dysfunction in Aged Patients- A Multi-center, Case Control, Randomized Clinical Trail |
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Date of first enrolment:
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September 1, 2018 |
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Target sample size:
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550 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02927522 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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China
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Contacts
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Name:
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Diansan Su, M.D., Ph.D. |
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Address:
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Telephone:
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+8618616514088 |
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Email:
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diansansu@yahoo.com |
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Affiliation:
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Name:
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Xiaoxue Hu |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Diansan Su, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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RenJi Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Elder than 60 years old
2. Speak Chinese Mandarin
3. Those who will undergo knee or hip replacement
4. Signed the inform consent
5. American Society of Anesthesiologists classification I to III
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. unwillingness to comply with the protocol or procedures.
5. Can not communicated with Chinese Mandarin
6. Existing bradycardiac arrhythmia(Heart rate <60 bpm for any reasons)
7. Existing gastrointestinal ulcer
8. Existing urinary incontinence
9. Existing asthma or chronic obstructive pulmonary disease
10. Allegory to Donepezil
Age minimum:
60 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Femoral Head Necrosis
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Osteoarthritis
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Intervention(s)
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Drug: Placebo
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Drug: Donepezil
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Primary Outcome(s)
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The incidence of postoperative delirium after surgery
[Time Frame: 1 to 7 days after surgery]
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The incidence of POCD 7 days(or before leaving hospital ) after surgery
[Time Frame: 7 days after surgery or before leaving hospital]
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Secondary Outcome(s)
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POCD incidence 1 months after surgery
[Time Frame: 1 months after surgery]
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Secondary ID(s)
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RJ20161003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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