<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/NCT03788447</url>
  </required_header>
  <id_info>
    <org_study_id>AJIRB-MED-THE-18-410</org_study_id>
    <nct_id>NCT03788447</nct_id>
  </id_info>
  <brief_title>Effect of Pneumoperitoneum on Remifentanil Requirements in the Surgical Pleth Index-guided Analgesia</brief_title>
  <official_title>Effect of Pneumoperitoneum on Remifentanil Requirements in the Surgical Pleth Index-guided Analgesia for Laparoscopic Gastrectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ajou University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ajou University School of Medicine</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to investigate the effect of pneumoperitoneum on&#xD;
      remifentanil requirements in the surgical pleth index-guided analgesia for laparoscopic&#xD;
      gastrectomy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 4, 2019</start_date>
  <completion_date type="Actual">September 5, 2019</completion_date>
  <primary_completion_date type="Actual">September 5, 2019</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>total dose of remifentanil</measure>
    <time_frame>through study completion, an average of 2 hours</time_frame>
    <description>total dose of remifentanil to maintain for surgical pleth index &lt; 50</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>High CO2 group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>end tidal CO2 : 40-45 mmHg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low CO2 group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>end tidal CO2 : 30-35 mmHg</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High end-tidal CO2</intervention_name>
    <description>maintaining of end-tidal CO2 with the range of 40-45 mmHg</description>
    <arm_group_label>High CO2 group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low CO2 group</intervention_name>
    <description>maintaining of end-tidal CO2 with the range of 30-35 mmHg</description>
    <arm_group_label>Low CO2 group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  laparoscopic gastrectomy under general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  atypical hemoglobin disease, infective state, cardiovascular disease, peripheral&#xD;
             vascular disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine</name>
      <address>
        <city>Suwon</city>
        <state>Seoul</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>December 24, 2018</study_first_submitted>
  <study_first_submitted_qc>December 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>January 6, 2021</last_update_submitted>
  <last_update_submitted_qc>January 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ajou University School of Medicine</investigator_affiliation>
    <investigator_full_name>Ji Eun Kim</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumoperitoneum</mesh_term>
  </condition_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/NCT03788447
org study id: AJIRB-MED-THE-18-410
nct id: NCT03788447
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The primary purpose of this study is to investigate the effect of pneumoperitoneum on
      remifentanil requirements in the surgical pleth index-guided analgesia for laparoscopic
      gastrectomy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: total dose of remifentanil
time frame: through study completion, an average of 2 hours
description: total dose of remifentanil to maintain for surgical pleth index < 50
arm group label: High CO2 group
arm group type: Experimental
description: end tidal CO2 : 40-45 mmHg
arm group label: Low CO2 group
arm group type: Placebo Comparator
description: end tidal CO2 : 30-35 mmHg
intervention type: Other
intervention name: High end-tidal CO2
description: maintaining of end-tidal CO2 with the range of 40-45 mmHg
arm group label: High CO2 group
intervention type: Other
intervention name: Low CO2 group
description: maintaining of end-tidal CO2 with the range of 30-35 mmHg
arm group label: Low CO2 group
criteria: 
gender: All
minimum age: 19 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Ajou University School of Medicine
investigator full name: Ji Eun Kim
investigator title: Assistant professor
mesh term: Pneumoperitoneum