<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/NCT01725607</url>
  </required_header>
  <id_info>
    <org_study_id>20121101</org_study_id>
    <nct_id>NCT01725607</nct_id>
  </id_info>
  <brief_title>Postoperative Sleep Quality in Patients Undergoing Thoracic Surgery With Different Types of Anesthesia Management</brief_title>
  <official_title>Postoperative Sleep Quality in Patients Undergoing Thoracic Surgery With Different Types of Anesthesia Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China Medical University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China Medical University, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We designed a study to determine whether a single dose of dexmedetomidine or thoracic&#xD;
      epidural anesthesia combined with general anesthesia would provide hemodynamic stability,&#xD;
      reduce stress hormone responses, inhibit inflammatory cytokine secretion, and improve sleep&#xD;
      quality in patients after thoracic surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We designed a prospective, single-blinded, randomized, and controlled study to determine&#xD;
      whether a single dose of dexmedetomidine or thoracic epidural anesthesia combined with&#xD;
      general anesthesia would provide hemodynamic stability, reduce stress hormone responses,&#xD;
      inhibit inflammatory cytokine secretion, and improve sleep quality in patients after thoracic&#xD;
      surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</primary_completion_date>
  <phase>Phase 4</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>inflammatory cytokine secretion and postoperative sleep quality</measure>
    <time_frame>immediately before anesthesia (T1), 5 min after endotracheal intubation (T2), immediately after incision (T3), 5 min after OLV initiation (T4), 5 min after double-lung ventilation initiation (T5), and immediately after extubation (T6)</time_frame>
    <description>Primary outcomes were inflammatory cytokine secretion and postoperative sleep quality, which was measured with the BIS data on first and second postoperative nights.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>amine secretion during the surgical period and hemodynamic stability</measure>
    <time_frame>immediately before anesthesia (T1), 5 min after endotracheal intubation (T2), immediately after incision (T3), 5 min after OLV initiation (T4), 5 min after double-lung ventilation initiation (T5), and immediately after extubation (T6)</time_frame>
    <description>amine (epinephrine and norepinephrine) secretion during the surgical period and hemodynamic stability</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">219</enrollment>
  <condition>General Anesthesia, Thoracic Epidural Anesthesia</condition>
  <arm_group>
    <arm_group_label>the control group (Group C)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>general anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>general anesthesia combined with dexmedetomidine infusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>general anesthesia combined with 1 μg/kg dexmedetomidine infusion after induction (Group D)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>general anesthesia combined with TEA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>general anesthesia combined with TEA (Group E)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>general anesthesia combined with dexmedetomidine infusion</intervention_name>
    <description>general anesthesia combined with 1 μg/kg dexmedetomidine infusion after induction (Group D)</description>
    <arm_group_label>general anesthesia combined with dexmedetomidine infusion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>general anesthesia combined with TEA</intervention_name>
    <description>general anesthesia combined with TEA (Group E)</description>
    <arm_group_label>general anesthesia combined with TEA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  lung surgery&#xD;
&#xD;
          -  one-lung ventilation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  body mass index exceeding 30 kg/m2,&#xD;
&#xD;
          -  autonomic dysfunction,&#xD;
&#xD;
          -  cardiovascular disease,&#xD;
&#xD;
          -  neurological or psychiatric diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hong Ma, M.D.,PhD.</last_name>
    <role>Study Chair</role>
    <affiliation>Dept. of Anesthesiology, the First Hospital of CMU</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anesthesiology, the First Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2013</verification_date>
  <study_first_submitted>November 3, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>July 7, 2015</last_update_submitted>
  <last_update_submitted_qc>July 7, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 8, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>China Medical University, China</investigator_affiliation>
    <investigator_full_name>Wen-fei Tan</investigator_full_name>
    <investigator_title>associate professor</investigator_title>
  </responsible_party>
  <keyword>dexmedetomidine, thoracic epidural anesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Dissection</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
    <mesh_term>Anesthetics</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/NCT01725607
org study id: 20121101
nct id: NCT01725607
lead sponsor: 
has dmc: Yes
We designed a study to determine whether a single dose of dexmedetomidine or thoracic
      epidural anesthesia combined with general anesthesia would provide hemodynamic stability,
      reduce stress hormone responses, inhibit inflammatory cytokine secretion, and improve sleep
      quality in patients after thoracic surgery.
We designed a prospective, single-blinded, randomized, and controlled study to determine
      whether a single dose of dexmedetomidine or thoracic epidural anesthesia combined with
      general anesthesia would provide hemodynamic stability, reduce stress hormone responses,
      inhibit inflammatory cytokine secretion, and improve sleep quality in patients after thoracic
      surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: inflammatory cytokine secretion and postoperative sleep quality
time frame: immediately before anesthesia (T1), 5 min after endotracheal intubation (T2), immediately after incision (T3), 5 min after OLV initiation (T4), 5 min after double-lung ventilation initiation (T5), and immediately after extubation (T6)
description: Primary outcomes were inflammatory cytokine secretion and postoperative sleep quality, which was measured with the BIS data on first and second postoperative nights.
measure: amine secretion during the surgical period and hemodynamic stability
time frame: immediately before anesthesia (T1), 5 min after endotracheal intubation (T2), immediately after incision (T3), 5 min after OLV initiation (T4), 5 min after double-lung ventilation initiation (T5), and immediately after extubation (T6)
description: amine (epinephrine and norepinephrine) secretion during the surgical period and hemodynamic stability
arm group label: the control group (Group C)
arm group type: No Intervention
description: general anesthesia
arm group label: general anesthesia combined with dexmedetomidine infusion
arm group type: Experimental
description: general anesthesia combined with 1 μg/kg dexmedetomidine infusion after induction (Group D)
arm group label: general anesthesia combined with TEA
arm group type: Experimental
description: general anesthesia combined with TEA (Group E)
intervention type: Drug
intervention name: general anesthesia combined with dexmedetomidine infusion
description: general anesthesia combined with 1 μg/kg dexmedetomidine infusion after induction (Group D)
arm group label: general anesthesia combined with dexmedetomidine infusion
intervention type: Procedure
intervention name: general anesthesia combined with TEA
description: general anesthesia combined with TEA (Group E)
arm group label: general anesthesia combined with TEA
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Hong Ma, M.D.,PhD.
role: Study Chair
affiliation: Dept. of Anesthesiology, the First Hospital of CMU
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: China Medical University, China
investigator full name: Wen-fei Tan
investigator title: associate professor
mesh term: Aortic Dissection
mesh term: Dexmedetomidine
mesh term: Anesthetics