<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/NCT02199067</url>
  </required_header>
  <id_info>
    <org_study_id>PIAG1</org_study_id>
    <nct_id>NCT02199067</nct_id>
  </id_info>
  <brief_title>Measurement of Exhaled Propofol</brief_title>
  <acronym>PIAG1</acronym>
  <official_title>Measurement of Exhaled Propofol During a Total Intravenous Anesthesia With Propofol and Remifentanil</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Erlangen-Nürnberg Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Erlangen-Nürnberg Medical School</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Propofol is a common intravenous anaesthetic drug used for anaesthesia induction and for&#xD;
      permanent infusion to maintain anaesthesia (total intravenous anaesthesia). Different to the&#xD;
      volatile anaesthetics (feedback concentrations in exhaled breathing gas) piloting of an total&#xD;
      intravenous anaesthesia with propofol is done only by experience of the anaesthetist or&#xD;
      according to pharmacokinetic models. In this study we want to investigate if the exhaled&#xD;
      fraction of propofol is a potential measurement parameter for piloting anaesthesia. Exhaled&#xD;
      propofol will be measured with an electrochemical sensor developed by &quot;Drägerwerk AG &amp; Co.&#xD;
      KGaA&quot;. Exhaled propofol levels will be compared with the corresponding arterial serum&#xD;
      concentrations of propofol. Furthermore we investigate the correlation of exhaled propofol&#xD;
      levels with the Bispectral Index (BIS).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    technical difficulties of probe measurement&#xD;
  </why_stopped>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">April 2019</completion_date>
  <primary_completion_date type="Actual">December 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>exhaled propofol levels in breathing gas</measure>
    <time_frame>continous recording during the whole anaesthesia (duration depents on surgery, between 2 and 12 hours)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>propofol concentration in arterial blood serum</measure>
    <time_frame>samples taken during anaesthesia (13 blood samples), duration of anaesthesia depends on surgery, 2 to 12 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bispectral Index (BIS)</measure>
    <time_frame>continous recording during the whole anaesthesia (duration depents on surgery, between 2 and 12 hours)</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Anaesthesia With Propofol</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      arterial blood samples (serum)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        -  patients undergoing elective surgery&#xD;
&#xD;
          -  total intravenous anaesthesia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA (American Society of Anaesthesiologists) classification I &amp; II&#xD;
&#xD;
          -  Body-Mass-Index &lt; 35&#xD;
&#xD;
          -  elective surgery with the necessity of an arterial catheter&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chronic obstructive lung disease&#xD;
&#xD;
          -  bronchial asthma&#xD;
&#xD;
          -  smokers with more than 5 packyears&#xD;
&#xD;
          -  peripheral artery occlusive disease&#xD;
&#xD;
          -  diabetes mellitus&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Erlangen</city>
        <state>Bavaria</state>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>April 16, 2019</last_update_submitted>
  <last_update_submitted_qc>April 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Erlangen-Nürnberg Medical School</investigator_affiliation>
    <investigator_full_name>Tino Münster</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <!-- 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/NCT02199067
org study id: PIAG1
nct id: NCT02199067
lead sponsor: 
has dmc: No
Propofol is a common intravenous anaesthetic drug used for anaesthesia induction and for
      permanent infusion to maintain anaesthesia (total intravenous anaesthesia). Different to the
      volatile anaesthetics (feedback concentrations in exhaled breathing gas) piloting of an total
      intravenous anaesthesia with propofol is done only by experience of the anaesthetist or
      according to pharmacokinetic models. In this study we want to investigate if the exhaled
      fraction of propofol is a potential measurement parameter for piloting anaesthesia. Exhaled
      propofol will be measured with an electrochemical sensor developed by "Drägerwerk AG & Co.
      KGaA". Exhaled propofol levels will be compared with the corresponding arterial serum
      concentrations of propofol. Furthermore we investigate the correlation of exhaled propofol
      levels with the Bispectral Index (BIS).
observational model: Case-Only
time perspective: Prospective
measure: exhaled propofol levels in breathing gas
time frame: continous recording during the whole anaesthesia (duration depents on surgery, between 2 and 12 hours)
measure: propofol concentration in arterial blood serum
time frame: samples taken during anaesthesia (13 blood samples), duration of anaesthesia depends on surgery, 2 to 12 hours
measure: Bispectral Index (BIS)
time frame: continous recording during the whole anaesthesia (duration depents on surgery, between 2 and 12 hours)
arterial blood samples (serum)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University of Erlangen-Nürnberg Medical School
investigator full name: Tino Münster
investigator title: Prof. Dr.