<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/NCT02993718</url>
  </required_header>
  <id_info>
    <org_study_id>WatchPAT</org_study_id>
    <nct_id>NCT02993718</nct_id>
  </id_info>
  <brief_title>Sedation by Dexmedetomidine and Propofol</brief_title>
  <official_title>Comparison of the Upper Airway Patency by Dexmedetomidine and Propofol Used for Sedation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Bundang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Bundang Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Under the hypothesis that dexmedetomidine sedation would result in less upper airway&#xD;
      obstruction, we evaluated the occurrence of upper airway collapse or the requirement of&#xD;
      airway intervention in patients with obstructive sleep apnea during dexmedetomidine or&#xD;
      propofol sedation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</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>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The occurrence of upper airway obstruction</measure>
    <time_frame>During the sedation period, an average of 3 hours.</time_frame>
    <description>When end-tidal carbon dioxide was not detected in spite of the respiratory effort during the sedation period, the case will be regarded as the occurrence of upper airway obstruction.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Anesthesia, Spinal</condition>
  <arm_group>
    <arm_group_label>Dexmedetomidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intraoperative sedation is performed by using dexmedetomidine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Propofol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intraoperative sedation is performed by using propofol</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>As a loading dose, 0.5 μg/kg dexmedetomidine was administered over 10 min, which was then administered continuously at a dose of 0.2-0.8 μg/kg/h. Sedation was maintained at modified observer's assessment of alertness/sedation scale 3</description>
    <arm_group_label>Dexmedetomidine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>Propofol was infused continuously via a target-controlled infusion device, and the effect-site concentration was maintained with a range of 0.5-2.0 μg/ml. Sedation was maintained at modified observer's assessment of alertness/sedation scale 3</description>
    <arm_group_label>Propofol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Surgery under spinal anesthesia&#xD;
&#xD;
          -  Intraoperative sedation&#xD;
&#xD;
          -  American Society of Anesthesiology physical status 1 or 2&#xD;
&#xD;
          -  Apnea/hypopnea index 5-14/h in Watch-PAT 200 analysis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anatomical defects on upper respiratory tract&#xD;
&#xD;
          -  Psychotic disorder&#xD;
&#xD;
          -  Drug addition&#xD;
&#xD;
          -  Alcohol addition&#xD;
&#xD;
          -  body mass index ≥ 35 kg/m2&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam</city>
        <state>Gyeonggi</state>
        <zip>463-707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>December 11, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>September 12, 2017</last_update_submitted>
  <last_update_submitted_qc>September 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Bundang Hospital</investigator_affiliation>
    <investigator_full_name>Hyo-Seok Na</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
    <mesh_term>Propofol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02993718
org study id: WatchPAT
nct id: NCT02993718
lead sponsor: 
has dmc: No
Under the hypothesis that dexmedetomidine sedation would result in less upper airway
      obstruction, we evaluated the occurrence of upper airway collapse or the requirement of
      airway intervention in patients with obstructive sleep apnea during dexmedetomidine or
      propofol sedation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: The occurrence of upper airway obstruction
time frame: During the sedation period, an average of 3 hours.
description: When end-tidal carbon dioxide was not detected in spite of the respiratory effort during the sedation period, the case will be regarded as the occurrence of upper airway obstruction.
arm group label: Dexmedetomidine
arm group type: Experimental
description: Intraoperative sedation is performed by using dexmedetomidine.
arm group label: Propofol
arm group type: Experimental
description: Intraoperative sedation is performed by using propofol
intervention type: Drug
intervention name: Dexmedetomidine
description: As a loading dose, 0.5 μg/kg dexmedetomidine was administered over 10 min, which was then administered continuously at a dose of 0.2-0.8 μg/kg/h. Sedation was maintained at modified observer's assessment of alertness/sedation scale 3
arm group label: Dexmedetomidine
intervention type: Drug
intervention name: Propofol
description: Propofol was infused continuously via a target-controlled infusion device, and the effect-site concentration was maintained with a range of 0.5-2.0 μg/ml. Sedation was maintained at modified observer's assessment of alertness/sedation scale 3
arm group label: Propofol
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Bundang Hospital
investigator full name: Hyo-Seok Na
investigator title: Principal investigator
mesh term: Dexmedetomidine
mesh term: Propofol
sharing ipd: No