<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/NCT01691001</url>
  </required_header>
  <id_info>
    <org_study_id>4-2011-0430</org_study_id>
    <nct_id>NCT01691001</nct_id>
  </id_info>
  <brief_title>Effect of Dexmedetomidine on Sevoflurane Requirements and Emergence Agitation in Children Undergoing Ambulatory Surgery</brief_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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Although the aetiology of emergence agitation (EA) derives from multiple factors, it is a&#xD;
      frequent side effect of sevoflurane anaesthesia in children. Dexmedetomidine, a potent&#xD;
      selective α2-adrenergic agonist, can reduce the doses of hypnotics, opioids, analgesics, and&#xD;
      anaesthetics that must be concomitantly administered. This study was conducted to assess the&#xD;
      effect of dexmedetomidine infusion on sevoflurane requirements and recovery profiles with EA&#xD;
      in children undergoing ambulatory surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2011</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <primary_completion_date type="Actual">March 2012</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the reduction rate of ET-sevo in achieving BIS scores from 45-50</measure>
    <time_frame>2 hour(during whole operation period)</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Ambulation Difficulty</condition>
  <arm_group>
    <arm_group_label>dexmedetomidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>normal saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>dexmedetomidine(vs saline) 1 mcg/kg iv bolus during 10minutes, and then, 0.1 mcg/kg/h dexmedetomidine(vs saline) was infused.</description>
    <arm_group_label>dexmedetomidine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>normal saline</intervention_name>
    <arm_group_label>placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA class I&#xD;
&#xD;
          -  obtaining written informed consent from the parents&#xD;
&#xD;
          -  aged 1-5 years, and weighing &lt;20 kg who were undergoing ambulatory hernioplasty or&#xD;
             orchiopexy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  mental retardation&#xD;
&#xD;
          -  developmental delays&#xD;
&#xD;
          -  neurological or psychiatric illnesses&#xD;
&#xD;
          -  coagulation disorder&#xD;
&#xD;
          -  spinal anomalies&#xD;
&#xD;
          -  bilateral procedures&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Severance Hospital</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 2012</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>September 18, 2012</last_update_submitted>
  <last_update_submitted_qc>September 18, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 24, 2012</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>Mobility Limitation</mesh_term>
  </condition_browse>
  <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/NCT01691001
org study id: 4-2011-0430
nct id: NCT01691001
lead sponsor: 
has dmc: No
Although the aetiology of emergence agitation (EA) derives from multiple factors, it is a
      frequent side effect of sevoflurane anaesthesia in children. Dexmedetomidine, a potent
      selective α2-adrenergic agonist, can reduce the doses of hypnotics, opioids, analgesics, and
      anaesthetics that must be concomitantly administered. This study was conducted to assess the
      effect of dexmedetomidine infusion on sevoflurane requirements and recovery profiles with EA
      in children undergoing ambulatory surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: the reduction rate of ET-sevo in achieving BIS scores from 45-50
time frame: 2 hour(during whole operation period)
arm group label: dexmedetomidine
arm group type: Experimental
arm group label: placebo group
arm group type: Placebo Comparator
description: normal saline
intervention type: Drug
intervention name: Dexmedetomidine
description: dexmedetomidine(vs saline) 1 mcg/kg iv bolus during 10minutes, and then, 0.1 mcg/kg/h dexmedetomidine(vs saline) was infused.
arm group label: dexmedetomidine
intervention type: Drug
intervention name: normal saline
arm group label: placebo group
criteria: 
gender: Male
minimum age: 1 Year
maximum age: 5 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Mobility Limitation
mesh term: Dexmedetomidine