<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/NCT03273231</url>
  </required_header>
  <id_info>
    <org_study_id>4-2017-0475</org_study_id>
    <nct_id>NCT03273231</nct_id>
  </id_info>
  <brief_title>The Effect of Ketamine on Immune Function and Prognosis in Patients Undergoing Colorectal Cancer Resection</brief_title>
  <official_title>The Effect of Ketamine on Immune Function and Prognosis in Patients Undergoing Colorectal Cancer Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</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>
      Systemic inflammation caused by surgery may aggravate immunosuppression in immunocompromised&#xD;
      cancer patients. The natural killer (NK) cell is a critical part of anti-tumor immunity.&#xD;
      ketamine, a N-methyl-D-asparate receptor antangonist, has anti-inflammatory activity and&#xD;
      opioid-sparing effect. This study investigate the effect of intraopertaive ketamine&#xD;
      administration on immune function in patients undergoing laparoscopic colorectal cancer&#xD;
      resection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">July 2020</completion_date>
  <primary_completion_date type="Anticipated">July 2020</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>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>natural killer cell cytotoxicity</measure>
    <time_frame>Baseline</time_frame>
    <description>Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>natural killer cell cytotoxicity</measure>
    <time_frame>1 hour after surgery</time_frame>
    <description>Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>natural killer cell cytotoxicity</measure>
    <time_frame>postoperative day 1</time_frame>
    <description>Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>natural killer cell cytotoxicity</measure>
    <time_frame>postoperative day 2</time_frame>
    <description>Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>proinflammatory cytokine</measure>
    <time_frame>Baseline</time_frame>
    <description>Inflammtory response is assesssed by measuring levels of proinflammtory cytokines.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>proinflammatory cytokine</measure>
    <time_frame>1 hour after surgery</time_frame>
    <description>Inflammtory response is assesssed by measuring levels of proinflammtory cytokines.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>proinflammatory cytokine</measure>
    <time_frame>postoperative day 1</time_frame>
    <description>Inflammtory response is assesssed by measuring levels of proinflammtory cytokines.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>proinflammatory cytokine</measure>
    <time_frame>postoperative day 2</time_frame>
    <description>Inflammtory response is assesssed by measuring levels of proinflammtory cytokines.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>recurrence</measure>
    <time_frame>1 year after surgery</time_frame>
    <description>Cancer recurrence is evaluated 1 year after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>metastasis</measure>
    <time_frame>1 year after surgery</time_frame>
    <description>Cancer metastasis is evaluated 1 year after surgery.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>ketamine group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ketamine is administered intravenously with a loading dose of 0.25 mg/kg at 5 minutes before surgery, followed by an infusion rate of 0.05 mg/kg/h to the end of surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>0.9% saline solution</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketamine</intervention_name>
    <description>Ketamine is administered intravenously with a loading dose of 0.25 mg/kg at 5 minutes before surgery, followed by an infusion rate of 0.05 mg/kg/h to the end of surgery.</description>
    <arm_group_label>ketamine group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>0.9% saline solution</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient between 20 and 80 of age with ASA physical status Ⅰ-Ⅲ&#xD;
&#xD;
          -  patient scheduled for laparoscopic colorectal cancer resection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA physical status Ⅳ&#xD;
&#xD;
          -  severe hepatorenal disease&#xD;
&#xD;
          -  heart failure&#xD;
&#xD;
          -  infection&#xD;
&#xD;
          -  increased intracranial pressure, seizure&#xD;
&#xD;
          -  preoperative chemotherapy&#xD;
&#xD;
          -  immune or endocrine disease&#xD;
&#xD;
          -  metastasis to other organ&#xD;
&#xD;
          -  problem with communication&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  body mass index &gt; 35 kg/m2&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jin Sun Cho, MD</last_name>
    <phone>82-2-2228-5448</phone>
    <email>chjs0214@yuhs.ac</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jin Sun Cho, MD</last_name>
      <phone>82-2-2228-5448</phone>
      <email>chjs0214@yuhs.ac</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>January 15, 2019</last_update_submitted>
  <last_update_submitted_qc>January 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketamine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03273231
org study id: 4-2017-0475
nct id: NCT03273231
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Systemic inflammation caused by surgery may aggravate immunosuppression in immunocompromised
      cancer patients. The natural killer (NK) cell is a critical part of anti-tumor immunity.
      ketamine, a N-methyl-D-asparate receptor antangonist, has anti-inflammatory activity and
      opioid-sparing effect. This study investigate the effect of intraopertaive ketamine
      administration on immune function in patients undergoing laparoscopic colorectal cancer
      resection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: natural killer cell cytotoxicity
time frame: Baseline
description: Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).
measure: natural killer cell cytotoxicity
time frame: 1 hour after surgery
description: Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).
measure: natural killer cell cytotoxicity
time frame: postoperative day 1
description: Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).
measure: natural killer cell cytotoxicity
time frame: postoperative day 2
description: Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).
measure: proinflammatory cytokine
time frame: Baseline
description: Inflammtory response is assesssed by measuring levels of proinflammtory cytokines.
measure: proinflammatory cytokine
time frame: 1 hour after surgery
description: Inflammtory response is assesssed by measuring levels of proinflammtory cytokines.
measure: proinflammatory cytokine
time frame: postoperative day 1
description: Inflammtory response is assesssed by measuring levels of proinflammtory cytokines.
measure: proinflammatory cytokine
time frame: postoperative day 2
description: Inflammtory response is assesssed by measuring levels of proinflammtory cytokines.
measure: recurrence
time frame: 1 year after surgery
description: Cancer recurrence is evaluated 1 year after surgery.
measure: metastasis
time frame: 1 year after surgery
description: Cancer metastasis is evaluated 1 year after surgery.
arm group label: ketamine group
arm group type: Experimental
description: Ketamine is administered intravenously with a loading dose of 0.25 mg/kg at 5 minutes before surgery, followed by an infusion rate of 0.05 mg/kg/h to the end of surgery.
arm group label: control group
arm group type: Placebo Comparator
description: 0.9% saline solution
intervention type: Drug
intervention name: Ketamine
description: Ketamine is administered intravenously with a loading dose of 0.25 mg/kg at 5 minutes before surgery, followed by an infusion rate of 0.05 mg/kg/h to the end of surgery.
arm group label: ketamine group
intervention type: Drug
intervention name: Saline
description: 0.9% saline solution
arm group label: control group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jin Sun Cho, MD
phone: 82-2-2228-5448
email: chjs0214@yuhs.ac
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Ketamine
sharing ipd: No