<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/NCT02220400</url>
  </required_header>
  <id_info>
    <org_study_id>KPPOCD</org_study_id>
    <nct_id>NCT02220400</nct_id>
  </id_info>
  <brief_title>Ketamine Prevent POCD</brief_title>
  <acronym>KPPOCD</acronym>
  <official_title>Low Dose Ketamine Prevent the Postoperative Cognitive Dysfunction in Aged Patients Underwent Orthopaedic Surgery，a Randomized Control Double Blinded Multicenter Clinical Trail</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RenJi Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Previous study demonstrated that neuroinflammation induced by surgery is the main cause of&#xD;
      the postoperative cognitive dysfunction. As an agonist of NMDA receptor, ketamine is proved&#xD;
      to be an anti-inflammation agent. In present study investigators hypothesized that low dose&#xD;
      ketamine would prevent the cognition decline after orthopedic surgery in aged patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">September 2016</completion_date>
  <primary_completion_date type="Anticipated">September 2016</primary_completion_date>
  <phase>N/A</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>Short-term cognitive changes after surgery</measure>
    <time_frame>The day before surgery and 7 days after surgery (or before leave hospital)</time_frame>
    <description>Investigators would use mini-mental state examination(MMSE), Visual reproduction test,digit symbol，digit span,color trail test and Stroop color and word test for measuring the short-term cognitive changes of patients after surgery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Long-term cognitive changes after surgery</measure>
    <time_frame>The day before surgery and 2 months after surgery</time_frame>
    <description>Investigators would use mini-mental state examination(MMSE), Visual reproduction test,digit symbol，digit span,color trail test and Stroop color and word test for measuring the long-term cognitive changes of patients after surgery.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">484</enrollment>
  <condition>Necrosis of Femoral Head</condition>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Ketamine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ketamine infusion group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Normal saline infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketamine</intervention_name>
    <arm_group_label>Ketamine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elder than 60&#xD;
&#xD;
          -  Easily communicated with Chinese&#xD;
&#xD;
          -  Selected to kneel or hip replacement&#xD;
&#xD;
          -  Agree to take part into this clinical trail&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Existing cerebral disease， or have a history of neurological and psychiatric disease&#xD;
             including AD, stroke and psychosis&#xD;
&#xD;
          -  Existing cognitive impairment as evidenced by Mini-Mental State Examination scores&#xD;
             below 24&#xD;
&#xD;
          -  Several audition or vision disorder&#xD;
&#xD;
          -  Preoperative systolic Blood pressure over 190mmHg or diastolic pressure &gt;100mmHg&#xD;
&#xD;
          -  Existing a history of hyperthyroidism&#xD;
&#xD;
          -  Patient with glaucoma&#xD;
&#xD;
          -  Unwillingness to comply with the protocol or procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Shanghai Tongji Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200065</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Xiaoqing Zhang, M.S.</last_name>
      <email>xq_820175@163.com</email>
    </contact>
    <investigator>
      <last_name>Xiaoqing Zhang, M.S.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Renji Hospital, School of Medicine, Shanghai Jiaotong University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200127</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Diansan Su, Dr.</last_name>
      <phone>0086-21-68383702</phone>
      <email>diansansu@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Diansan Su, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shanghai Pudong New Area People's Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Lizhi Li, M.S.</last_name>
      <email>Fmlilizhi@sina.com.cn</email>
    </contact>
    <investigator>
      <last_name>Lizhi Li, M.S.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>August 18, 2014</last_update_submitted>
  <last_update_submitted_qc>August 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>RenJi Hospital</investigator_affiliation>
    <investigator_full_name>diansan su</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>Postoperative cognitive dysfunction</keyword>
  <keyword>Ketamine</keyword>
  <keyword>Surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Necrosis</mesh_term>
    <mesh_term>Postoperative Cognitive Complications</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketamine</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/NCT02220400
org study id: KPPOCD
nct id: NCT02220400
lead sponsor: 
has dmc: Yes
Previous study demonstrated that neuroinflammation induced by surgery is the main cause of
      the postoperative cognitive dysfunction. As an agonist of NMDA receptor, ketamine is proved
      to be an anti-inflammation agent. In present study investigators hypothesized that low dose
      ketamine would prevent the cognition decline after orthopedic surgery in aged patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Short-term cognitive changes after surgery
time frame: The day before surgery and 7 days after surgery (or before leave hospital)
description: Investigators would use mini-mental state examination(MMSE), Visual reproduction test,digit symbol，digit span,color trail test and Stroop color and word test for measuring the short-term cognitive changes of patients after surgery.
measure: Long-term cognitive changes after surgery
time frame: The day before surgery and 2 months after surgery
description: Investigators would use mini-mental state examination(MMSE), Visual reproduction test,digit symbol，digit span,color trail test and Stroop color and word test for measuring the long-term cognitive changes of patients after surgery.
arm group label: Ketamine
arm group type: Experimental
description: Ketamine infusion group
arm group label: Placebo
arm group type: Placebo Comparator
description: Normal saline infusion
intervention type: Drug
intervention name: Ketamine
arm group label: Ketamine
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
facility: 
contact: 
investigator: 
facility: 
contact: 
investigator: 
facility: 
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: RenJi Hospital
investigator full name: diansan su
investigator title: Dr.
mesh term: Necrosis
mesh term: Postoperative Cognitive Complications
mesh term: Cognitive Dysfunction
mesh term: Ketamine