<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/NCT03772106</url>
  </required_header>
  <id_info>
    <org_study_id>2017/0164</org_study_id>
    <nct_id>NCT03772106</nct_id>
  </id_info>
  <brief_title>Effect of Sevoflurane and Propofol on Hepato-splanchnic Pressure and Flow During Hepatobiliary Surgery</brief_title>
  <official_title>Effect of Sevoflurane and Propofol on Hepato-splanchnic Pressure and Flow During Hepatobiliary Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Ghent</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Blood loss in hepatobiliary surgery is correlated with an increase in postoperative&#xD;
      complications (e.g. transfusion related lung injury and tumor recurrence) and reduced&#xD;
      longterm survival. To reduce morbidity and mortality in hepatobiliary surgery, modulation of&#xD;
      the hepato-splanchnic blood flow and pressure is used. In liver surgery pharmacological&#xD;
      modulations are widely used to prevent blood loss. For pharmacological modulation central&#xD;
      venous pressure is commonly used to reduce the pressure in the inferior vena cava, however&#xD;
      little is known about pharmacological effect on blood flow in the hepatic artery and portal&#xD;
      vein. The modulation of the hepato-splanchnic blood flow can also play an important role, not&#xD;
      only for prevention of blood loss but also for survival of the organs (e.g. ischemic injury&#xD;
      due to low flow).&#xD;
&#xD;
      Volatile anesthetics induce a dose-dependent reduction of the hepato-splanchninc blood flow.&#xD;
      Propofol however, increases hepatic blood flow when compared with volatile anesthetics.&#xD;
      Pharmacological modulation of hepato-splanchnic bloodflow with anesthetics such as&#xD;
      sevoflurane or propofol can play an important role in modulation of ischemia/reperfusion&#xD;
      injury and survival of organs.&#xD;
&#xD;
      The aim of the study is to determine and to compare the effect of sevoflurane versus propofol&#xD;
      on hepatosplanchnic pressure and hepato-splanchnic blood flow during hepatobiliary surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients receive standardized anesthesia care for hepato-biliary surgery according to the&#xD;
      existing anesthesia protocol. The type of anaesthesia will be randomized : propolipid (TIV)&#xD;
      or sevorane(inhalation).&#xD;
&#xD;
      At designated times, hemodynamic variables will be recorded.&#xD;
&#xD;
      These will include:&#xD;
&#xD;
        -  HF (/min)&#xD;
&#xD;
        -  CVP (mmHg),&#xD;
&#xD;
        -  MAP (mmHg)&#xD;
&#xD;
        -  CI (L/min.m2)&#xD;
&#xD;
        -  PPV (pulse pressure variation). Hemodynamic measurement will be done using PiCCO&#xD;
           catheter.&#xD;
&#xD;
      The hemodynamic measurements will be compared and related to hepato-splanchnic blood flow and&#xD;
      pressure measurements performed by the surgeon:&#xD;
&#xD;
        -  Flow v. porta&#xD;
&#xD;
        -  Flow art. hepatica&#xD;
&#xD;
        -  Pressure v. porta&#xD;
&#xD;
        -  Pressure v. cava The flow measurements will be done using ultrasound transit time ﬂow&#xD;
           measurements TTFM (Medi-Stim AS, Oslo, Norway).&#xD;
&#xD;
      At the same time pressure measurements will be obtained in portal vein and caval vein using a&#xD;
      25-gauge needle which is directly placed in the vein. Both flow and pressure will be&#xD;
      simultaneously recorded (VeriQ 4122, Medi-Stim AS, Oslo, Norway). Both measurements will be&#xD;
      done during apnea to minimize the effect of ventilation on pressure &amp; flow. Flow values will&#xD;
      be expressed in ml per minute, pressure values will be expressed in mmHg.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 8, 2017</start_date>
  <completion_date type="Actual">December 4, 2018</completion_date>
  <primary_completion_date type="Actual">January 27, 2018</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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in blood flow in hepatic artery and main portal vein</measure>
    <time_frame>From randomization until the end of the whipple surgery</time_frame>
    <description>flow/pressure measurements with echo probe and needle</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>need of inotropic and/or vasopressor support</measure>
    <time_frame>From start anesthesia until end of anesthesia</time_frame>
    <description>total dose of inotropic and vasopressor medication that were used during surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>amount of blood loss</measure>
    <time_frame>From start of surgery until end of surgery</time_frame>
    <description>amount of blood loss at end of surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>amount of colloids given during surgery</measure>
    <time_frame>From start of surgery until end of surgery</time_frame>
    <description>total amount of colloids given during surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>General Anesthesia</condition>
  <arm_group>
    <arm_group_label>Group P</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group P : Propolipid 1% dose : variable to keep BIS between 40 and 60</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group S</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group S : Sevoflurane dose : variable to keep BIS between 40 and 60</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol Fresenius</intervention_name>
    <description>Propolipid 1% : IV</description>
    <arm_group_label>Group P</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>sevorane</intervention_name>
    <description>sevorane Quick fill (sevoflurane) : inhalation</description>
    <arm_group_label>Group S</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult ≥ 18 years (Female or Male)&#xD;
&#xD;
          -  ASA I - II - III&#xD;
&#xD;
          -  Able to comprehend, sign and date the written informed consent document to participate&#xD;
             in the clinical trial.&#xD;
&#xD;
          -  Scheduled for hepato-biliary surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy for the medication&#xD;
&#xD;
          -  Renal insufficiency (SCr &gt; 2 mg/dl)&#xD;
&#xD;
          -  Severe heart failure (EF &lt; 25%)&#xD;
&#xD;
          -  Hemodynamic instable patients&#xD;
&#xD;
          -  Arterial fibrillation&#xD;
&#xD;
          -  Sepsis&#xD;
&#xD;
          -  BMI &gt; 40&#xD;
&#xD;
          -  Severe coagulopathy (INR &gt; 2)&#xD;
&#xD;
          -  Thrombocytopenia (&lt; 80 x 10³ /µL)&#xD;
&#xD;
          -  History of severe postoperative nausea &amp; vomiting&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jurgten Van Limmen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UZ Ghent</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Ghent</name>
      <address>
        <city>Gent</city>
        <state>Oost-Vlaanderen</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>December 10, 2018</last_update_submitted>
  <last_update_submitted_qc>December 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hepato-splanchnic blood flow</keyword>
  <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>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/NCT03772106
org study id: 2017/0164
nct id: NCT03772106
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Blood loss in hepatobiliary surgery is correlated with an increase in postoperative
      complications (e.g. transfusion related lung injury and tumor recurrence) and reduced
      longterm survival. To reduce morbidity and mortality in hepatobiliary surgery, modulation of
      the hepato-splanchnic blood flow and pressure is used. In liver surgery pharmacological
      modulations are widely used to prevent blood loss. For pharmacological modulation central
      venous pressure is commonly used to reduce the pressure in the inferior vena cava, however
      little is known about pharmacological effect on blood flow in the hepatic artery and portal
      vein. The modulation of the hepato-splanchnic blood flow can also play an important role, not
      only for prevention of blood loss but also for survival of the organs (e.g. ischemic injury
      due to low flow).

      Volatile anesthetics induce a dose-dependent reduction of the hepato-splanchninc blood flow.
      Propofol however, increases hepatic blood flow when compared with volatile anesthetics.
      Pharmacological modulation of hepato-splanchnic bloodflow with anesthetics such as
      sevoflurane or propofol can play an important role in modulation of ischemia/reperfusion
      injury and survival of organs.

      The aim of the study is to determine and to compare the effect of sevoflurane versus propofol
      on hepatosplanchnic pressure and hepato-splanchnic blood flow during hepatobiliary surgery.
All patients receive standardized anesthesia care for hepato-biliary surgery according to the
      existing anesthesia protocol. The type of anaesthesia will be randomized : propolipid (TIV)
      or sevorane(inhalation).

      At designated times, hemodynamic variables will be recorded.

      These will include:

        -  HF (/min)

        -  CVP (mmHg),

        -  MAP (mmHg)

        -  CI (L/min.m2)

        -  PPV (pulse pressure variation). Hemodynamic measurement will be done using PiCCO
           catheter.

      The hemodynamic measurements will be compared and related to hepato-splanchnic blood flow and
      pressure measurements performed by the surgeon:

        -  Flow v. porta

        -  Flow art. hepatica

        -  Pressure v. porta

        -  Pressure v. cava The flow measurements will be done using ultrasound transit time ﬂow
           measurements TTFM (Medi-Stim AS, Oslo, Norway).

      At the same time pressure measurements will be obtained in portal vein and caval vein using a
      25-gauge needle which is directly placed in the vein. Both flow and pressure will be
      simultaneously recorded (VeriQ 4122, Medi-Stim AS, Oslo, Norway). Both measurements will be
      done during apnea to minimize the effect of ventilation on pressure & flow. Flow values will
      be expressed in ml per minute, pressure values will be expressed in mmHg.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Change in blood flow in hepatic artery and main portal vein
time frame: From randomization until the end of the whipple surgery
description: flow/pressure measurements with echo probe and needle
measure: need of inotropic and/or vasopressor support
time frame: From start anesthesia until end of anesthesia
description: total dose of inotropic and vasopressor medication that were used during surgery
measure: amount of blood loss
time frame: From start of surgery until end of surgery
description: amount of blood loss at end of surgery
measure: amount of colloids given during surgery
time frame: From start of surgery until end of surgery
description: total amount of colloids given during surgery
arm group label: Group P
arm group type: Experimental
description: Group P : Propolipid 1% dose : variable to keep BIS between 40 and 60
arm group label: Group S
arm group type: Experimental
description: Group S : Sevoflurane dose : variable to keep BIS between 40 and 60
intervention type: Drug
intervention name: Propofol Fresenius
description: Propolipid 1% : IV
arm group label: Group P
intervention type: Drug
intervention name: sevorane
description: sevorane Quick fill (sevoflurane) : inhalation
arm group label: Group S
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jurgten Van Limmen, MD
role: Principal Investigator
affiliation: UZ Ghent
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Propofol
mesh term: Sevoflurane
sharing ipd: No