<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/NCT03788564</url>
  </required_header>
  <id_info>
    <org_study_id>4-2017-0727</org_study_id>
    <nct_id>NCT03788564</nct_id>
  </id_info>
  <brief_title>The Association of Cardiac Ion Channel Related Gene Polymorphism and Prolonged QTc Interval After Endotracheal Intubation</brief_title>
  <official_title>The Association of Cardiac Ion Channel Related Gene Polymorphism and Prolonged QTc Interval After Endotracheal Intubation</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>Yes</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>
      The QTc interval is affected by heart rate, medications and changes in the autonomic nervous&#xD;
      system. The endotracheal laryngoscopy, the necessary step during general anesthesia, prolongs&#xD;
      QTc interval. Changes in the flow of ion currents could result from the genetic variation of&#xD;
      myocardial ion channels by gene polymorphism. This study is to investigate the association of&#xD;
      cardiac ion channel related gene polymorphism and prolonged QTc interval after endotracheal&#xD;
      intubation in adult patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 24, 2017</start_date>
  <completion_date type="Actual">May 3, 2020</completion_date>
  <primary_completion_date type="Actual">May 3, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>QTc interval</measure>
    <time_frame>Before anesthesia, Before laryngoscopy, Right after laryngoscopy, 5 minutes after laryngoscopy</time_frame>
    <description>QTc interval prolongs followed by laryngoscopy due to changes in the autonomic nervous system. The restoration of the prolonged QTc could also be affected by the balance of autonomic nervous system or changes in the related cardiac ion channels.</description>
  </primary_outcome>
  <enrollment type="Actual">315</enrollment>
  <condition>Emergence Delirium</condition>
  <eligibility>
    <study_pop>
      <textblock>
        20-65 years old, scheduled for general anesthesia requiring direct laryngoscopy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 20-65 years old&#xD;
&#xD;
          2. scheduled for general anesthesia requiring direct laryngoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients taking antihypertensive medication (beta-blocker, CCB)&#xD;
&#xD;
          2. patients taking other medications known to affect QTc interval&#xD;
&#xD;
          3. Patients with abnormal ECG and prolonged QTc (&gt;500 msec)&#xD;
&#xD;
          4. Diabetes, liver disease, kidney disease, heart failure, congenital heart disease&#xD;
&#xD;
          5. Severe electrolyte imbalance&#xD;
&#xD;
          6. illiterate, foreigners who cannot understand the consent form&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>December 25, 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>September 28, 2020</last_update_submitted>
  <last_update_submitted_qc>September 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2020</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>Emergence Delirium</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/NCT03788564
org study id: 4-2017-0727
nct id: NCT03788564
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The QTc interval is affected by heart rate, medications and changes in the autonomic nervous
      system. The endotracheal laryngoscopy, the necessary step during general anesthesia, prolongs
      QTc interval. Changes in the flow of ion currents could result from the genetic variation of
      myocardial ion channels by gene polymorphism. This study is to investigate the association of
      cardiac ion channel related gene polymorphism and prolonged QTc interval after endotracheal
      intubation in adult patients.
observational model: Case-Control
time perspective: Prospective
measure: QTc interval
time frame: Before anesthesia, Before laryngoscopy, Right after laryngoscopy, 5 minutes after laryngoscopy
description: QTc interval prolongs followed by laryngoscopy due to changes in the autonomic nervous system. The restoration of the prolonged QTc could also be affected by the balance of autonomic nervous system or changes in the related cardiac ion channels.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Emergence Delirium