<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/NCT03263078</url>
  </required_header>
  <id_info>
    <org_study_id>CF16113B</org_study_id>
    <nct_id>NCT03263078</nct_id>
  </id_info>
  <brief_title>Difference Between Inhalation Anesthesia and Total Intravenous Anesthesia in Free Flap Surgery</brief_title>
  <official_title>Difference Between Inhalation Anesthesia and Total Intravenous Anesthesia in Free Flap Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taichung Veterans General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taichung Veterans General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the difference between total intravenous anesthesia&#xD;
      to inhaled anesthesia in free flap surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to perform a randomized controlled trial to examine the effects of&#xD;
      different anesthetics on intraoperative hemodynamic stability during free flap surgery and&#xD;
      postoperative complications&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">October 30, 2019</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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with postoperative pulmonary complication</measure>
    <time_frame>1 day</time_frame>
    <description>A radiologist who was unaware of the group assignment evaluated the images and confirmed any PPCs, such as pulmonary edema, pneumonia, pleural effusion or atelectasis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean arterial blood pressure, MAP (mmHg)</measure>
    <time_frame>1 day</time_frame>
    <description>Measure MAP hourly (T0: First data after monitor instrumentation, T1: first hour, T2: second hour, Tend: at the end of surgery) and compare the difference between groups)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac index , CI (L·min-1·m-2))</measure>
    <time_frame>1 day</time_frame>
    <description>Measure CI hourly (T0: First data after monitor instrumentation, T1: first hour, T2: second hour, Tend: at the end of surgery) and compare the difference between groups)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systemic vascular resistance index, SVRI (dynes · sec · cm-5)</measure>
    <time_frame>1 day</time_frame>
    <description>Measure SVRI hourly (T0: First data after monitor instrumentation, T1: first hour, T2: second hour, Tend: at the end of surgery) and compare the difference between groups)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke Volume Variation , SVV (%)</measure>
    <time_frame>1 day</time_frame>
    <description>Measure SVV hourly (T0: First data after monitor instrumentation, T1: first hour, T2: second hour, Tend: at the end of surgery) and compare the difference between groups)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>TIVA with Propofol in free flap surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Total intravenous anesthesia(TIVA) with Propofol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sevoflurane in free flap surgery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Inhalation anesthesia with Sevoflurane</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>For the maintenance of anesthesia, we used 2% propofol (Fresofol®, Fresenius Kabi, Germany) administered by the target controlled infusion (TCI) system (Orchestra® Base Primea; Fresenius Kabi, Germany) in Schnider mode with an effect concentration (Ce) of 2.5-3.5 µg ml-1</description>
    <arm_group_label>TIVA with Propofol in free flap surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sevoflurane</intervention_name>
    <description>Anesthesia was maintained using 1-3% sevoflurane (ULTANE®, AbbVie Inc., USA) in the Sevoflurane group.</description>
    <arm_group_label>Sevoflurane in free flap surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        Patients who need head and neck cancer excision and free flap reconstruction surgery&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. preoperative cognitive dysfunction, NYHA CHF &gt; III or LVEF &lt; 30%&#xD;
&#xD;
          2. preoperative documented obstructive or restrictive lung disease&#xD;
&#xD;
          3. liver cirrhosis; severe chronic renal insufficiency (GFR &lt; 30 ml·min-1·1.73 m-2.)&#xD;
&#xD;
          4. peripheral arterial occlusive disease expected to be a contraindication for PiCCO&#xD;
             catheter insertion&#xD;
&#xD;
          5. Active cardiac arrhythmias that were assumed to preclude valid assessment using&#xD;
             arterial pulse contour analysis&#xD;
&#xD;
          6. anticipated bilateral femoral arterial and central venous catheterization when the&#xD;
             jugular and subclavian veins were not available due to surgical extent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yi-Ting Chang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Anesthesiology Department, Taichung Veterans General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung</city>
        <state>Taiwain</state>
        <zip>407</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>June 28, 2022</last_update_submitted>
  <last_update_submitted_qc>June 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>inhalation,intravenous anesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Aspiration</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propofol</mesh_term>
    <mesh_term>Sevoflurane</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03263078
org study id: CF16113B
nct id: NCT03263078
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare the difference between total intravenous anesthesia
      to inhaled anesthesia in free flap surgery.
The aim of this study is to perform a randomized controlled trial to examine the effects of
      different anesthetics on intraoperative hemodynamic stability during free flap surgery and
      postoperative complications
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Number of patients with postoperative pulmonary complication
time frame: 1 day
description: A radiologist who was unaware of the group assignment evaluated the images and confirmed any PPCs, such as pulmonary edema, pneumonia, pleural effusion or atelectasis
measure: Mean arterial blood pressure, MAP (mmHg)
time frame: 1 day
description: Measure MAP hourly (T0: First data after monitor instrumentation, T1: first hour, T2: second hour, Tend: at the end of surgery) and compare the difference between groups)
measure: Cardiac index , CI (L·min-1·m-2))
time frame: 1 day
description: Measure CI hourly (T0: First data after monitor instrumentation, T1: first hour, T2: second hour, Tend: at the end of surgery) and compare the difference between groups)
measure: Systemic vascular resistance index, SVRI (dynes · sec · cm-5)
time frame: 1 day
description: Measure SVRI hourly (T0: First data after monitor instrumentation, T1: first hour, T2: second hour, Tend: at the end of surgery) and compare the difference between groups)
measure: Stroke Volume Variation , SVV (%)
time frame: 1 day
description: Measure SVV hourly (T0: First data after monitor instrumentation, T1: first hour, T2: second hour, Tend: at the end of surgery) and compare the difference between groups)
arm group label: TIVA with Propofol in free flap surgery
arm group type: Experimental
description: Total intravenous anesthesia(TIVA) with Propofol
arm group label: Sevoflurane in free flap surgery
arm group type: Active Comparator
description: Inhalation anesthesia with Sevoflurane
intervention type: Drug
intervention name: Propofol
description: For the maintenance of anesthesia, we used 2% propofol (Fresofol®, Fresenius Kabi, Germany) administered by the target controlled infusion (TCI) system (Orchestra® Base Primea; Fresenius Kabi, Germany) in Schnider mode with an effect concentration (Ce) of 2.5-3.5 µg ml-1
arm group label: TIVA with Propofol in free flap surgery
intervention type: Drug
intervention name: Sevoflurane
description: Anesthesia was maintained using 1-3% sevoflurane (ULTANE®, AbbVie Inc., USA) in the Sevoflurane group.
arm group label: Sevoflurane in free flap surgery
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Yi-Ting Chang, MD
role: Principal Investigator
affiliation: Anesthesiology Department, Taichung Veterans General Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Respiratory Aspiration
mesh term: Propofol
mesh term: Sevoflurane
sharing ipd: Undecided