<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/NCT02185430</url>
  </required_header>
  <id_info>
    <org_study_id>4-2014-0306</org_study_id>
    <nct_id>NCT02185430</nct_id>
  </id_info>
  <brief_title>Effects of Dexmedetomidine on Respiratory Mechanics and Oxygenation During One Lung Ventilation With Chronic Obstructive Lung Disease</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>
      COPD is often associated with the airflow limitation and the pulmonary hyperinflation. During&#xD;
      the one-lung ventilation (OLV), COPD patients' physiologic dead space increases and&#xD;
      hypercapnia may develop. In addition, an alveolar overdistention by the pulmonary&#xD;
      hyperinflation would divert pulmonary blood flow and impair arterial oxygenation.&#xD;
      Dexmedetomidine has both vasoconstricting and vasodilatatory effects on a peripheral&#xD;
      vasculature and a smooth muscle but its effects on bronchial smooth muscle is unknown. The&#xD;
      investigators will evaluate the effects of dexmedetomidine (bolus of 1.0 μg kg-1 over 10 min&#xD;
      followed by a continuous infusion at 0.5 μg kg-1 h-1 infusion during one-lung ventilation) as&#xD;
      bronchodilator in COPD patients when administered during surgery with the one lung&#xD;
      ventilation. If result successfully shows the effect of dexmedetomidine as a predominantly a&#xD;
      vasodilator on bronchial tree, the investigators study can support the dexmedetomidine as a&#xD;
      vasodilator for pulmonary vessels and bronchial smooth muscle and as an excellent adjunct to&#xD;
      anesthetic agents in COPD patients during the OLV.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</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>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change of the oxygenation</measure>
    <time_frame>At two-lung ventilation (T1) , 20 min after of one-lung ventilation (T2), 30 mins after Dex or placebo saline infusion (T3), 60 mins after Dex or placebo saline infusion (T4), at the termination of surgery in TLV (T5)</time_frame>
    <description>PaO2/FiO2 ratio</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>COPD, One Lung Ventilation</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>saline solution</description>
  </arm_group>
  <arm_group>
    <arm_group_label>dexmedetomidine group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>dexmedetomidine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>saline infusion</intervention_name>
    <description>saline infusion, bolus of 1.0 μg kg-1 over 10 min followed by a continuous infusion at 0.5 μg kg-1 h-1 infusion during one-lung ventilation, intravenous</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dexmedetomidine infusion</intervention_name>
    <description>dexmedetomidine, bolus of 1.0 μg kg-1 over 10 min followed by a continuous infusion at 0.5 μg kg-1 h-1 infusion during one-lung ventilation, intravenous</description>
    <arm_group_label>dexmedetomidine group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Above 40 years of age&#xD;
&#xD;
          2. American Society of Anesthesiologists (ASA) Physical Status I, II, III.&#xD;
&#xD;
          3. COPD diagnosed , criteria ( on preop. PFT : FEV1 &lt; 80%, FEV1 / FVC &lt; 70% after&#xD;
             bronchodilator)&#xD;
&#xD;
          4. thoracic surgical procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. severe functional liver or kidney disease&#xD;
&#xD;
          2. diagnosed HF ( NYHA class &gt;3)&#xD;
&#xD;
          3. arrhythmia or received treatment with antiarrythmic drug .&#xD;
&#xD;
          4. exceed BMI &gt; 30 kg/ m2&#xD;
&#xD;
          5. bradycardia (HR &lt;50 bpm)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Young Jun Oh, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine</affiliation>
  </overall_official>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>October 11, 2015</last_update_submitted>
  <last_update_submitted_qc>October 11, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 14, 2015</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/NCT02185430
org study id: 4-2014-0306
nct id: NCT02185430
lead sponsor: 
has dmc: No
COPD is often associated with the airflow limitation and the pulmonary hyperinflation. During
      the one-lung ventilation (OLV), COPD patients' physiologic dead space increases and
      hypercapnia may develop. In addition, an alveolar overdistention by the pulmonary
      hyperinflation would divert pulmonary blood flow and impair arterial oxygenation.
      Dexmedetomidine has both vasoconstricting and vasodilatatory effects on a peripheral
      vasculature and a smooth muscle but its effects on bronchial smooth muscle is unknown. The
      investigators will evaluate the effects of dexmedetomidine (bolus of 1.0 μg kg-1 over 10 min
      followed by a continuous infusion at 0.5 μg kg-1 h-1 infusion during one-lung ventilation) as
      bronchodilator in COPD patients when administered during surgery with the one lung
      ventilation. If result successfully shows the effect of dexmedetomidine as a predominantly a
      vasodilator on bronchial tree, the investigators study can support the dexmedetomidine as a
      vasodilator for pulmonary vessels and bronchial smooth muscle and as an excellent adjunct to
      anesthetic agents in COPD patients during the OLV.
allocation: Randomized
intervention model: Parallel Assignment
masking: Triple (Participant, Care Provider, Investigator)
measure: The change of the oxygenation
time frame: At two-lung ventilation (T1) , 20 min after of one-lung ventilation (T2), 30 mins after Dex or placebo saline infusion (T3), 60 mins after Dex or placebo saline infusion (T4), at the termination of surgery in TLV (T5)
description: PaO2/FiO2 ratio
arm group label: Control group
arm group type: Placebo Comparator
description: saline solution
arm group label: dexmedetomidine group
arm group type: Active Comparator
description: dexmedetomidine
intervention type: Drug
intervention name: saline infusion
description: saline infusion, bolus of 1.0 μg kg-1 over 10 min followed by a continuous infusion at 0.5 μg kg-1 h-1 infusion during one-lung ventilation, intravenous
arm group label: Control group
intervention type: Drug
intervention name: dexmedetomidine infusion
description: dexmedetomidine, bolus of 1.0 μg kg-1 over 10 min followed by a continuous infusion at 0.5 μg kg-1 h-1 infusion during one-lung ventilation, intravenous
arm group label: dexmedetomidine group
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Young Jun Oh, MD,PhD
role: Principal Investigator
affiliation: Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
responsible party type: Sponsor
mesh term: Dexmedetomidine