<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/NCT02261675</url>
  </required_header>
  <id_info>
    <org_study_id>Macbar DEX</org_study_id>
    <nct_id>NCT02261675</nct_id>
  </id_info>
  <brief_title>Reduction in MACbar of Sevoflurane by Dexmedetomidine in Children</brief_title>
  <official_title>Dexmedetomidine Augments Block of Sympathetic Responses to Skin Incision During Sevoflurane Anesthesia in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cai Li</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Affiliated Hospital, Sun Yat-Sen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study was designed to define the interaction of intravenous infusion of dexmedetomidine,&#xD;
      an a2-adrenergic agonist, and sevoflurane in children having surgery by using the minimum&#xD;
      alveolar concentration which can block adrenergic and cardiovascular responses to&#xD;
      incision(MACbar) of sevoflurane as the measure of anesthetic potency.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators observed the effects of different doses of dexmedetomidine on the minimum&#xD;
      alveolar concentration of sevoflurane to blockade adrenergic response to surgical incision in&#xD;
      50% of children (MACBAR). And to explore the safety of use of dexmedetomidine in pediatric&#xD;
      patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</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>Crossover Assignment</intervention_model>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the end-tidal sevoflurane concentration to blockade adrenergic response to surgical incision in 50% of children (MACBAR)</measure>
    <time_frame>at once before incision and 5 min period after incision</time_frame>
    <description>A predetermined steady-state end-tidal sevoflurane concentration(4%) was maintained for at least 15 min before skin incision.we observed the change in Mean Blood Pressure or Heart rate to determined the next end-tidal sevoflurane concentration.Followed the modified Dixon up and down method to obtain MACBAR of every child.The MACBAR of sevoflurane and its 95% confidence interval were calculated by Sum Average method.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Children</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>children undergoing selective lower abdominal surgery received saline before induction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>D1 group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>children undergoing selective lower abdominal surgery received a bolus dose of 0.5 µg/kg dexmedetomidine followed by a continuous infusion of 0.5 µg/kg /h before induction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>D2 group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>children undergoing selective lower abdominal surgery received a bolus dose of 1.0µg/kg dexmedetomidine followed by a continuous infusion of 1.0 µg/kg /h before induction</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dexmedetomidine</intervention_name>
    <description>children received intravenous infusion with a bolus dose dexmedetomidine and followed by a continuous infusion before induction. use sevoflurane for induction and a steady-state end-tidal sevoflurane concentration was maintained for at least 15 min before skin incision.</description>
    <arm_group_label>D1 group</arm_group_label>
    <arm_group_label>D2 group</arm_group_label>
    <other_name>precedex</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged 2 to 6 yr&#xD;
&#xD;
          -  American Society of anesthesiologists I or II&#xD;
&#xD;
          -  scheduled to have general anesthesia and to have skin incisions on the abdomen&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  anemia or abnormal preoperative electrolyte concentrations&#xD;
&#xD;
          -  a history of cardiovascular or central nervous system diseases&#xD;
&#xD;
          -  a history of pulmonary disease&#xD;
&#xD;
          -  known hepatic or renal disease&#xD;
&#xD;
          -  a body weight exceeding 50% of the upper limit of ideal body weight for height&#xD;
&#xD;
          -  taking drugs with cardiovascular or central nervous system effects&#xD;
&#xD;
          -  use of any experimental drug within the past 30 days&#xD;
&#xD;
          -  allergy to any drug that may be administered during the study&#xD;
&#xD;
          -  exposure to general anesthesia within the previous 7 days&#xD;
&#xD;
          -  second- or third-degree atrioventricular block&#xD;
&#xD;
          -  taking drugs preoperatively that would interfere with MAC determination(e.g.,opioids&#xD;
             or sedatives)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xuan Ke Liu, Ph.d</last_name>
    <role>Principal Investigator</role>
    <affiliation>Departmeng of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University</affiliation>
  </overall_official>
  <results_reference>
    <citation>Albertin A, Casati A, Bergonzi P, Fano G, Torri G. Effects of two target-controlled concentrations (1 and 3 ng/ml) of remifentanil on MAC(BAR) of sevoflurane. Anesthesiology. 2004 Feb;100(2):255-9. doi: 10.1097/00000542-200402000-00012.</citation>
    <PMID>14739797</PMID>
  </results_reference>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>October 7, 2014</last_update_submitted>
  <last_update_submitted_qc>October 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>First Affiliated Hospital, Sun Yat-Sen University</investigator_affiliation>
    <investigator_full_name>Cai Li</investigator_full_name>
    <investigator_title>Department of Anesthesiology, First Affiliated Hospital, Sun Yat-Sen University</investigator_title>
  </responsible_party>
  <keyword>dexmedetomidine</keyword>
  <keyword>sevoflurane</keyword>
  <keyword>MAC bar</keyword>
  <keyword>drug interaction</keyword>
  <keyword>anesthesia</keyword>
  <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/NCT02261675
org study id: Macbar DEX
nct id: NCT02261675
lead sponsor: 
has dmc: Yes
The study was designed to define the interaction of intravenous infusion of dexmedetomidine,
      an a2-adrenergic agonist, and sevoflurane in children having surgery by using the minimum
      alveolar concentration which can block adrenergic and cardiovascular responses to
      incision(MACbar) of sevoflurane as the measure of anesthetic potency.
The investigators observed the effects of different doses of dexmedetomidine on the minimum
      alveolar concentration of sevoflurane to blockade adrenergic response to surgical incision in
      50% of children (MACBAR). And to explore the safety of use of dexmedetomidine in pediatric
      patients.
allocation: Randomized
intervention model: Crossover Assignment
masking: Double (Investigator, Outcomes Assessor)
measure: the end-tidal sevoflurane concentration to blockade adrenergic response to surgical incision in 50% of children (MACBAR)
time frame: at once before incision and 5 min period after incision
description: A predetermined steady-state end-tidal sevoflurane concentration(4%) was maintained for at least 15 min before skin incision.we observed the change in Mean Blood Pressure or Heart rate to determined the next end-tidal sevoflurane concentration.Followed the modified Dixon up and down method to obtain MACBAR of every child.The MACBAR of sevoflurane and its 95% confidence interval were calculated by Sum Average method.
arm group label: control group
arm group type: No Intervention
description: children undergoing selective lower abdominal surgery received saline before induction
arm group label: D1 group
arm group type: Experimental
description: children undergoing selective lower abdominal surgery received a bolus dose of 0.5 µg/kg dexmedetomidine followed by a continuous infusion of 0.5 µg/kg /h before induction
arm group label: D2 group
arm group type: Experimental
description: children undergoing selective lower abdominal surgery received a bolus dose of 1.0µg/kg dexmedetomidine followed by a continuous infusion of 1.0 µg/kg /h before induction
intervention type: Drug
intervention name: dexmedetomidine
description: children received intravenous infusion with a bolus dose dexmedetomidine and followed by a continuous infusion before induction. use sevoflurane for induction and a steady-state end-tidal sevoflurane concentration was maintained for at least 15 min before skin incision.
arm group label: D1 group
arm group label: D2 group
other name: precedex
criteria: 
gender: All
minimum age: 2 Years
maximum age: 6 Years
healthy volunteers: No
last name: Xuan Ke Liu, Ph.d
role: Principal Investigator
affiliation: Departmeng of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University
citation: Albertin A, Casati A, Bergonzi P, Fano G, Torri G. Effects of two target-controlled concentrations (1 and 3 ng/ml) of remifentanil on MAC(BAR) of sevoflurane. Anesthesiology. 2004 Feb;100(2):255-9. doi: 10.1097/00000542-200402000-00012.
PMID: 14739797
responsible party type: Sponsor-Investigator
investigator affiliation: First Affiliated Hospital, Sun Yat-Sen University
investigator full name: Cai Li
investigator title: Department of Anesthesiology, First Affiliated Hospital, Sun Yat-Sen University
mesh term: Dexmedetomidine