<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/NCT03234660</url>
  </required_header>
  <id_info>
    <org_study_id>H1706-132-861</org_study_id>
    <nct_id>NCT03234660</nct_id>
  </id_info>
  <brief_title>Dexmedetomidine and Neuroprotection in Children Undergoing General Anesthesia</brief_title>
  <official_title>The Effects of Dexmedetomidine on the Neurotoxicity From General Anesthesia Assessed by Plasma Glial Fibrillary Acidic Protein</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</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>
      Neuroapoptosis is induced by the administration of anesthetic agents to the young brain.&#xD;
      Recent studies showed that the a2-adrenoceptor agonist, dexmedetomidine plays a trophic role&#xD;
      during development and is neuroprotective in several settings of neuronal injury in animals.&#xD;
      We hypothesized that neuroprotective effect of dexmedetomidine would be associated with&#xD;
      evidence of brain injury detected by elevation of plasma concentration of glial fibrillary&#xD;
      acid protein in children undergoing general anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      GFAP measure&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">October 5, 2019</completion_date>
  <primary_completion_date type="Actual">October 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>Diagnostic</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glial fibrillary acid protein</measure>
    <time_frame>change from baseline glial fibrillary acid protein at 3 hours after the anesthetic induction</time_frame>
    <description>plasma was collected at the given specific time</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Dexmedetomidine</condition>
  <arm_group>
    <arm_group_label>Dexmedetomidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>dexmedetomidine infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine Hydrochloride</intervention_name>
    <description>dexmedetomidine 1mcg/kg loading and 0.5mcg/kg/hr continuous infusion during surgery</description>
    <arm_group_label>Dexmedetomidine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>control</intervention_name>
    <description>0.9% normal saline continuous infusion</description>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children undergoing general anesthesia longer than 3 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  past history of anesthesia&#xD;
&#xD;
          -  cardiopulmonary bypass&#xD;
&#xD;
          -  preexisting neurocognitive dysfunction&#xD;
&#xD;
          -  abnormalities of liver profile (aspartate transaminase &gt; 40 unit/L, alanine&#xD;
             aminotransferase &gt; 40 unit/L)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>3 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>SNUH</name>
      <address>
        <city>Seoul</city>
        <state>Jongro Gu</state>
        <zip>15710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>July 17, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>December 29, 2019</last_update_submitted>
  <last_update_submitted_qc>December 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Hee-Soo Kim</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</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/NCT03234660
org study id: H1706-132-861
nct id: NCT03234660
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Neuroapoptosis is induced by the administration of anesthetic agents to the young brain.
      Recent studies showed that the a2-adrenoceptor agonist, dexmedetomidine plays a trophic role
      during development and is neuroprotective in several settings of neuronal injury in animals.
      We hypothesized that neuroprotective effect of dexmedetomidine would be associated with
      evidence of brain injury detected by elevation of plasma concentration of glial fibrillary
      acid protein in children undergoing general anesthesia.
GFAP measure
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Glial fibrillary acid protein
time frame: change from baseline glial fibrillary acid protein at 3 hours after the anesthetic induction
description: plasma was collected at the given specific time
arm group label: Dexmedetomidine
arm group type: Experimental
description: dexmedetomidine infusion
arm group label: control
arm group type: Placebo Comparator
description: placebo infusion
intervention type: Drug
intervention name: Dexmedetomidine Hydrochloride
description: dexmedetomidine 1mcg/kg loading and 0.5mcg/kg/hr continuous infusion during surgery
arm group label: Dexmedetomidine
intervention type: Other
intervention name: control
description: 0.9% normal saline continuous infusion
arm group label: control
criteria: 
gender: All
minimum age: 1 Month
maximum age: 3 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Hee-Soo Kim
investigator title: Professor
mesh term: Dexmedetomidine