<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/NCT01687868</url>
  </required_header>
  <id_info>
    <org_study_id>4-2012-0351</org_study_id>
    <nct_id>NCT01687868</nct_id>
  </id_info>
  <brief_title>Evaluation of Efficacy and Safety of General Anesthesia Using Dexmedetomidine With Sevoflurane in Patients Undergoing Arthroscopic Shoulder Surgery: Preliminary Study</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients undergoing shoulder arthroscopy in the beach chair position may be at risk for&#xD;
      adverse neurologic events due to cerebral ischemia.&#xD;
&#xD;
      Dexmedetomidine, a potent alpha adrenoceptor agonist which dose-dependently reduces arterial&#xD;
      blood pressure and heart rate, decreases the hemodynamic and catecholamine response in the&#xD;
      perioperative period.&#xD;
&#xD;
      dexmedetomidine has an effect of peripheral vasoconstriction thus it is theologically&#xD;
      appropriate for reducing bleeding for arthroscopic operation field.&#xD;
&#xD;
      The aim of this study is to evaluate the efficacy and the safety of dexmedetomidine on&#xD;
      cerebral oxygen saturation, cognitive function, hemodynamic stability and operative field in&#xD;
      patients undergoing arthroscopic shoulder surgery in the beach-chair position.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Regional cerebral oxygen saturation value</measure>
    <time_frame>T1,T2,T3, T4, T5,T6, T7, T8, T9 time of post-dose during surgery</time_frame>
    <description>Before the anesthetic induction(T1), Before endotracheal intubation(T2), After endotracheal intubation(T3), Before the beach-chair position(T4), 5 minutes after the beach-chair position(T5), Before the operation(T6), 5 minutes after the incision(T7), After removal of the arthroscopy(T8), at the end of the operation(T9)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Arthroscopic Shoulder Surgery in the Beach-chair Position</condition>
  <arm_group>
    <arm_group_label>dexmedetomidine continuous infusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>dexmedetomidine 0.7mcg/kg/hr continuous infusion</description>
    <arm_group_label>dexmedetomidine continuous infusion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I-II&#xD;
&#xD;
          -  Aged between 20 and 70 year&#xD;
&#xD;
          -  general anesthesia for arthroscopic shoulder surgery in the beach-chair position&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Congestive heart failure, coronary artery occlusive disease&#xD;
&#xD;
          -  Bradycardia &lt; 50 BPM, 2nd degree &lt; AV block&#xD;
&#xD;
          -  Poorly controlled hypertension&#xD;
&#xD;
          -  ß blocker medication&#xD;
&#xD;
          -  Coagulopathy&#xD;
&#xD;
          -  Pregnancy, nursing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Anesthesiology and Pain Medicine,Yonsei University Health System</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>March 2014</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>March 4, 2014</last_update_submitted>
  <last_update_submitted_qc>March 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT01687868
org study id: 4-2012-0351
nct id: NCT01687868
lead sponsor: 
has dmc: Yes
Patients undergoing shoulder arthroscopy in the beach chair position may be at risk for
      adverse neurologic events due to cerebral ischemia.

      Dexmedetomidine, a potent alpha adrenoceptor agonist which dose-dependently reduces arterial
      blood pressure and heart rate, decreases the hemodynamic and catecholamine response in the
      perioperative period.

      dexmedetomidine has an effect of peripheral vasoconstriction thus it is theologically
      appropriate for reducing bleeding for arthroscopic operation field.

      The aim of this study is to evaluate the efficacy and the safety of dexmedetomidine on
      cerebral oxygen saturation, cognitive function, hemodynamic stability and operative field in
      patients undergoing arthroscopic shoulder surgery in the beach-chair position.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Regional cerebral oxygen saturation value
time frame: T1,T2,T3, T4, T5,T6, T7, T8, T9 time of post-dose during surgery
description: Before the anesthetic induction(T1), Before endotracheal intubation(T2), After endotracheal intubation(T3), Before the beach-chair position(T4), 5 minutes after the beach-chair position(T5), Before the operation(T6), 5 minutes after the incision(T7), After removal of the arthroscopy(T8), at the end of the operation(T9)
arm group label: dexmedetomidine continuous infusion
arm group type: Experimental
intervention type: Drug
intervention name: Dexmedetomidine
description: dexmedetomidine 0.7mcg/kg/hr continuous infusion
arm group label: dexmedetomidine continuous infusion
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Dexmedetomidine