<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04423276</url>
  </required_header>
  <id_info>
    <org_study_id>DNPQ20200523</org_study_id>
    <nct_id>NCT04423276</nct_id>
  </id_info>
  <brief_title>Efficiency of Donepezil in Elderly Patients for Prevention of POCD Dysfunction</brief_title>
  <official_title>Efficiency of Donepezil in Elderly Patients Undergoing Orthopedic Surgery Due to Underlying Postoperative Cognitive Dysfunction, a Multicenter Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tenth People's Hospital of Tongji Univeristy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>RenJi Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Postoperative cognitive dysfunction (POCD) occurs mainly in aged patients. POCD may increase&#xD;
      the mortality and morbidity. However, the mechanism of POCD is not clear yet and no effective&#xD;
      therapy method was proved. According to our previous study, the central cholinergic system&#xD;
      impaired by the anesthesia and surgery play a very important role in the POCD and donepezil&#xD;
      an acetylcholinesterase inhibitor can prevent the POCD after isoflurane anesthesia in aged&#xD;
      mice. Donepezil is a commercial medicine used for the Alzheimer Disease, which is tolerable&#xD;
      and has minimal adverse events. In present study a multi-center randomized case control study&#xD;
      was conducted and we hypothesized that donepezil attenuate the POCD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 14, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2021</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of POCD after the surgery.</measure>
    <time_frame>up to 7 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The incidence of postoperative delirium after surgery.</measure>
    <time_frame>1 to 7 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>POCD incidence one month, six months and one year after surgery.</measure>
    <time_frame>one month, six months and one year after surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">360</enrollment>
  <condition>Total Knee Arthroplasty</condition>
  <condition>Fracture of Head of Femur Articular Displaced</condition>
  <condition>Protrusion of Intervertebral Disc</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Donepezil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Donepezil</intervention_name>
    <description>Donepezil a cholinesterase inhibitor, 5mg(1 pill)/ day for 7 days Po, was administrated from the day before surgery.</description>
    <arm_group_label>Donepezil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo, 1 pill/ day for 7 days Po, was administrated from the day before surgery.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Elder than 60 years old&#xD;
&#xD;
          2. Speak Chinese Mandarin&#xD;
&#xD;
          3. Scheduled to undergo hip or knee replacement surgery and lumbar spine surgery&#xD;
&#xD;
          4. The operation time is more than 2 hours.&#xD;
&#xD;
          5. Signed the informed consent&#xD;
&#xD;
          6. American Society of Anesthesiologists (ASA) classification I-II&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Existing cerebral disease, or have a history of neurological and psychiatric diseases&#xD;
             including Alzheimer Disease, stroke, epilepsy and psychosis&#xD;
&#xD;
          2. Existing cognitive impairment as evidenced by Mini-Mental State Examination scores&#xD;
             below 24&#xD;
&#xD;
          3. Several audition or vision disorder&#xD;
&#xD;
          4. Patients with tumors or infections&#xD;
&#xD;
          5. Unwillingness to comply with the protocol or procedures&#xD;
&#xD;
          6. Can not communicate normally in Mandarin Chinese&#xD;
&#xD;
          7. Existing bradycardiac arrhythmia (Heart rate &lt;60 bpm for any reasons)&#xD;
&#xD;
          8. Existing gastrointestinal ulcer&#xD;
&#xD;
          9. Existing urinary incontinence&#xD;
&#xD;
         10. Existing asthma or chronic obstructive pulmonary disease&#xD;
&#xD;
         11. Postoperative admission to ICU&#xD;
&#xD;
         12. Allergic to donepezil&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Diansan Su</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesiology Renji Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Diansan Su, M.D., Ph.D.</last_name>
    <phone>+8618616514088</phone>
    <email>diansansu@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Renji Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200127</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Diansan Su</last_name>
      <phone>+862168383702</phone>
      <email>diansansu@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>June 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>December 28, 2020</last_update_submitted>
  <last_update_submitted_qc>December 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Donepezil</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04423276
org study id: DNPQ20200523
nct id: NCT04423276
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The incidence of POCD after the surgery.
time frame: up to 7 days
measure: The incidence of postoperative delirium after surgery.
time frame: 1 to 7 days after surgery
measure: POCD incidence one month, six months and one year after surgery.
time frame: one month, six months and one year after surgery
arm group label: Control
arm group type: Placebo Comparator
arm group label: Donepezil
arm group type: Experimental
intervention type: Drug
intervention name: Donepezil
description: Donepezil a cholinesterase inhibitor, 5mg(1 pill)/ day for 7 days Po, was administrated from the day before surgery.
arm group label: Donepezil
intervention type: Drug
intervention name: Placebo
description: Placebo, 1 pill/ day for 7 days Po, was administrated from the day before surgery.
arm group label: Control
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Diansan Su
role: Principal Investigator
affiliation: Department of Anesthesiology Renji Hospital
last name: Diansan Su, M.D., Ph.D.
phone: +8618616514088
email: diansansu@yahoo.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Donepezil