<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/NCT03817541</url>
  </required_header>
  <id_info>
    <org_study_id>Expiratory propofol gastro</org_study_id>
    <nct_id>NCT03817541</nct_id>
  </id_info>
  <brief_title>Expiratory and Plasma Propofol Concentration in Gastrological Surgery Patients</brief_title>
  <official_title>Expiratory and Plasma Propofol Concentration in Bariatric and Cholecystectomy Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oslo University 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>
      Determination of accuracy With Edmond (reg) expiratory propofol measurement Device, compared&#xD;
      With concommitant plasma samples of propofol&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Edmon (trade mark) is a New Device from BBraun, measuring the expiratory concentration of&#xD;
      propofol in anaesthetized patients.&#xD;
&#xD;
      The investigators will test the accuracy and stability of such measurements in comparison&#xD;
      With plasma propofol Levels.&#xD;
&#xD;
      The investigators will test during target Control infusion (Marsh model) and assumed stable&#xD;
      plasma Levels.&#xD;
&#xD;
      Plasma samples of propofol will be taken for comparison With exhaled propofol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 14, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 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>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>One Group of morbidly obese patients for bariatric surgery One Group of normal weight cholecystectomy</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>exhaled propofol concentration</measure>
    <time_frame>start of anaesthesia to end of anaesthesia, 2-3 hours in total</time_frame>
    <description>parts per billion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>propofol plasma concentration</measure>
    <time_frame>4-6 samples in the period between start and end of anaesthesia</time_frame>
    <description>microg pr ml</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>calculated plasma concentration</measure>
    <time_frame>From start of anaesthesia until end of anaesthesia, 1-3 hrs in total</time_frame>
    <description>Marsh model prediction, microg pr ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BIS</measure>
    <time_frame>from start of anaesthesia until end of anaestheisa, 1-3 hours in total</time_frame>
    <description>Bispectral index value, score = 0-100</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>calculated effect site concentration</measure>
    <time_frame>from start of anaesthesia until end of anaesthesia, 1-3 hours in total</time_frame>
    <description>Marsh model, microg pr ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EEG Power spectrum</measure>
    <time_frame>f</time_frame>
    <description>Spectral edge value (Hz)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EEG Power distribution</measure>
    <time_frame>from start of anaesthesia until end of anaesthesia, 1-3 hours in total</time_frame>
    <description>% representation relative Power of Alpha, Beta, Theta, Gamma band</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Bariatric Surgery Candidate</condition>
  <condition>Cholecystectomy</condition>
  <arm_group>
    <arm_group_label>Bariatric surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients due for bariatric surgery, BMI &gt; 30</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cholecystectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Normal weight patients due for cholecystectomies</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Edmon (reg), BBraun</intervention_name>
    <description>exhaled propofol will be compared With plasma propofol values</description>
    <arm_group_label>Bariatric surgery</arm_group_label>
    <arm_group_label>Cholecystectomy</arm_group_label>
    <other_name>propofol plasma sample</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Patients admitted to Oslo University Hospital, scheduled for elective laparoscopic&#xD;
             bariatric surgery or elective laparoscopic cholecystectomy.&#xD;
&#xD;
               -  Both genders.&#xD;
&#xD;
               -  Age 18-60 years, both inclusive.&#xD;
&#xD;
               -  BMI ≥ 20 kg/m2, 10 patients with BMI 20-30, and 10 patients with BMI &gt; 40&#xD;
&#xD;
               -  ASA classification I-III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Known hypersensitivity or other contraindication to propofol administered as Target&#xD;
             Controlled Infusion.&#xD;
&#xD;
               -  Patients which during a preoperative visit are deemed not to tolerate propofol&#xD;
                  bolus or infusion as administered by Target Controlled Infusion.&#xD;
&#xD;
               -  Ongoing neuroleptic medication.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dept of Anesthesiology, Oslo University Hospital, Ullevaal</name>
      <address>
        <city>Oslo</city>
        <zip>0407</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Johan Raeder</last_name>
      <phone>+47 92249669</phone>
      <email>johan.rader@medisin.uio.no</email>
    </contact>
    <investigator>
      <last_name>Johan Raeder</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>February 2, 2019</last_update_submitted>
  <last_update_submitted_qc>February 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Johan C Ræder</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propofol</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/NCT03817541
org study id: Expiratory propofol gastro
nct id: NCT03817541
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Determination of accuracy With Edmond (reg) expiratory propofol measurement Device, compared
      With concommitant plasma samples of propofol
Edmon (trade mark) is a New Device from BBraun, measuring the expiratory concentration of
      propofol in anaesthetized patients.

      The investigators will test the accuracy and stability of such measurements in comparison
      With plasma propofol Levels.

      The investigators will test during target Control infusion (Marsh model) and assumed stable
      plasma Levels.

      Plasma samples of propofol will be taken for comparison With exhaled propofol.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: One Group of morbidly obese patients for bariatric surgery One Group of normal weight cholecystectomy
primary purpose: Supportive Care
masking: None (Open Label)
measure: exhaled propofol concentration
time frame: start of anaesthesia to end of anaesthesia, 2-3 hours in total
description: parts per billion
measure: propofol plasma concentration
time frame: 4-6 samples in the period between start and end of anaesthesia
description: microg pr ml
measure: calculated plasma concentration
time frame: From start of anaesthesia until end of anaesthesia, 1-3 hrs in total
description: Marsh model prediction, microg pr ml
measure: BIS
time frame: from start of anaesthesia until end of anaestheisa, 1-3 hours in total
description: Bispectral index value, score = 0-100
measure: calculated effect site concentration
time frame: from start of anaesthesia until end of anaesthesia, 1-3 hours in total
description: Marsh model, microg pr ml
measure: EEG Power spectrum
time frame: f
description: Spectral edge value (Hz)
measure: EEG Power distribution
time frame: from start of anaesthesia until end of anaesthesia, 1-3 hours in total
description: % representation relative Power of Alpha, Beta, Theta, Gamma band
arm group label: Bariatric surgery
arm group type: Experimental
description: Patients due for bariatric surgery, BMI > 30
arm group label: Cholecystectomy
arm group type: Experimental
description: Normal weight patients due for cholecystectomies
intervention type: Device
intervention name: Edmon (reg), BBraun
description: exhaled propofol will be compared With plasma propofol values
arm group label: Bariatric surgery
arm group label: Cholecystectomy
other name: propofol plasma sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Johan C Ræder
investigator title: Professor
mesh term: Propofol
sharing ipd: Undecided