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Donepezil Attenuate Postoperative Cognitive Dysfunction (DAPOCD)

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ClinicalTrials.gov Identifier: NCT02927522
Recruitment Status : Unknown
Verified October 2016 by diansan su, RenJi Hospital.
Recruitment status was:  Not yet recruiting
First Posted : October 7, 2016
Last Update Posted : October 7, 2016
Sponsor:
Collaborators:
Shanghai Sixth Hospital
Shanghai Guanghua Hospital
Sanya People's Hospital
Information provided by (Responsible Party):
diansan su, RenJi Hospital

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Study Start Date : October 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control
Placebo was administrated
Drug: Placebo
Experimental: Donepezil
Donepezil (5mg/ day for 7 days) was administrated
Drug: Donepezil
An cholinesterase inhibitor




Primary Outcome Measures :
  1. The incidence of POCD 7 days(or before leaving hospital ) after surgery [ Time Frame: 7 days after surgery or before leaving hospital ]

Secondary Outcome Measures :
  1. The incidence of POCD 2 months after surgery [ Time Frame: 2 months after surgery ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927522


Contacts
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Contact: Diansan Su, M.D., Ph.D. +8618616514088 diansansu@yahoo.com

Sponsors and Collaborators
RenJi Hospital
Shanghai Sixth Hospital
Shanghai Guanghua Hospital
Sanya People's Hospital
Investigators
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Principal Investigator: Diansan Su, M.D., Ph.D. RenJi Hospital

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Responsible Party: diansan su, Dr., RenJi Hospital
ClinicalTrials.gov Identifier: NCT02927522     History of Changes
Other Study ID Numbers: RJ20161003
First Posted: October 7, 2016    Key Record Dates
Last Update Posted: October 7, 2016
Last Verified: October 2016
Keywords provided by diansan su, RenJi Hospital:
Postoperative Cognitive Dysfunction
Donepezil
Hip replacement
Knee replacement
Additional relevant MeSH terms:
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Necrosis
Cognitive Dysfunction
Pathologic Processes
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents