<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/NCT01720498</url>
  </required_header>
  <id_info>
    <org_study_id>4-2012-0581</org_study_id>
    <nct_id>NCT01720498</nct_id>
  </id_info>
  <brief_title>The Effect Site Concentration of Remifentanil for Preventing QTc Interval Prolongation During Intubation Under Propofol-remifentanil Anesthesia in Elderly Patients</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Severance Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Severance Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To find out the effect site concentration of remifentanil for preventing QTc interval&#xD;
      prolongation during intubation under propofol-remifentanil anesthesia in elderly patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The increase of Corrected QT (QTc) interval is associated with age. It is known that most&#xD;
      inhalation anesthetics or intravenous anesthetics can influence the QTc. In addition,&#xD;
      tracheal intubation during induction can stimulates sympathetic activity, which, as a&#xD;
      results, prolong the QTc interval. Therefore, the aim of study is to find out the effect site&#xD;
      concentration of remifentanil for preventing QTc interval prolongation during intubation&#xD;
      under propofol-remifentanil anesthesia in elderly patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The effect site concentration for preventing QTc interval prolongation</measure>
    <time_frame>2 min</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>General Surgery With Endotracheal Intubation</condition>
  <arm_group>
    <arm_group_label>Male</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To find out the effect site concentration of remifentanil for preventing QTc prolongation &lt; 15 sec during intubation : Dixon's up-and-down method</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Female</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To find out the effect site concentration of remifentanil for preventing QTc prolongation &lt; 15 sec during intubation : Dixon's up-and-down method</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>remifentanil</intervention_name>
    <description>The effect site concentration of remifentanil</description>
    <arm_group_label>Female</arm_group_label>
    <arm_group_label>Male</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 65 years ASA class I-II who received surgery with endotracheal intubation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  emergency surgery&#xD;
&#xD;
          -  electrocardiography abnormality&#xD;
&#xD;
          -  hypertension&#xD;
&#xD;
          -  diabetes mellitus&#xD;
&#xD;
          -  end stage renal disease&#xD;
&#xD;
          -  moderate to severe cardiac disease&#xD;
&#xD;
          -  moderate to severe liver dysfunction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>So Yeon Kim, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>June 16, 2013</last_update_submitted>
  <last_update_submitted_qc>June 16, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 18, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Severance Hospital</investigator_affiliation>
    <investigator_full_name>So Yeon Kim</investigator_full_name>
    <investigator_title>Clinical assistant professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Remifentanil</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/NCT01720498
org study id: 4-2012-0581
nct id: NCT01720498
lead sponsor: 
has dmc: No
To find out the effect site concentration of remifentanil for preventing QTc interval
      prolongation during intubation under propofol-remifentanil anesthesia in elderly patients
The increase of Corrected QT (QTc) interval is associated with age. It is known that most
      inhalation anesthetics or intravenous anesthetics can influence the QTc. In addition,
      tracheal intubation during induction can stimulates sympathetic activity, which, as a
      results, prolong the QTc interval. Therefore, the aim of study is to find out the effect site
      concentration of remifentanil for preventing QTc interval prolongation during intubation
      under propofol-remifentanil anesthesia in elderly patients.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: The effect site concentration for preventing QTc interval prolongation
time frame: 2 min
arm group label: Male
arm group type: Experimental
description: To find out the effect site concentration of remifentanil for preventing QTc prolongation < 15 sec during intubation : Dixon's up-and-down method
arm group label: Female
arm group type: Experimental
description: To find out the effect site concentration of remifentanil for preventing QTc prolongation < 15 sec during intubation : Dixon's up-and-down method
intervention type: Drug
intervention name: remifentanil
description: The effect site concentration of remifentanil
arm group label: Female
arm group label: Male
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: So Yeon Kim, MD, PhD
role: Principal Investigator
affiliation: Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Severance Hospital
investigator full name: So Yeon Kim
investigator title: Clinical assistant professor
mesh term: Remifentanil