<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/NCT01665079</url>
  </required_header>
  <id_info>
    <org_study_id>Propofol TCI obese</org_study_id>
    <nct_id>NCT01665079</nct_id>
  </id_info>
  <brief_title>Propofol Effect-Site Target Controlled Infusion in the Obese: Characterization of the Time Profile of Bispectral Index Response</brief_title>
  <official_title>Propofol Effect-Site Target Controlled Infusion in the Obese: Characterization of the Time Profile of Bispectral Index Response.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad del Desarrollo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad del Desarrollo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to characterize the Pharmacokinetic/Pharmacodynamic relationship of&#xD;
      a single bolus dose of propofol in obese patients and to extract a time to peak effect&#xD;
      (t-peak) from the estimated model parameters.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Target controlled infusion (TCI) is a technique to administer intravenous drugs that allows&#xD;
      rapid achievement and maintenance of predetermined drug concentrations, either in plasma (Cp)&#xD;
      or at the site of effect (Ce).&#xD;
&#xD;
      To characterize the time profile of propofol effect an additional parameter, the&#xD;
      equilibration half time between plasma and effect site (T1/2keo) needs to be incorporated in&#xD;
      the pharmacokinetic (PK) model.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2011</start_date>
  <completion_date type="Actual">November 2011</completion_date>
  <primary_completion_date type="Actual">November 2011</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Profile of Pharmacokinetic and Pharmacodynamic of an induction bolus dose of propofol in obese patients.</measure>
    <time_frame>1, 2, 3, 5, 7 and 10 minutes after the initial bolus dose or until BIS &gt; 75</time_frame>
    <description>Pharmacokinetic parameters (V1, V2, V3, CL, Q)&#xD;
Pharmacodynamic parameters (E0, Emax, C50, Gamma, t1/2Ke0, T peak )</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Propofol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>14 obese patients(IMC&gt;35 kg m-2) scheduled for laparoscopic bariatric surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>Propofol was administered by plasma TCI and a bolus dose was given by setting the initial plasma target between 12-16 μg/ml according to the anesthesiologist criteria. The protocol target range was selected based on previous experience using this model in the obese. After the patients reached this target, propofol infusion was stopped until the patients woke up (BIS&gt;75). No other drugs were given during this period. Facemask ventilation was assisted only if necessary to maintain SpO2 &gt; 90%. BIS data and propofol infusion data were automatically recorded every five seconds using the AnestFusor© program. Arterial blood samples of 4 ml for propofol assays were collected at 1, 2, 3, 5, 7 and 10 minutes after the initial bolus dose or until BIS &gt; 75. After the patient woke up the study was considered finished and propofol infusion was restarted according to the anesthesiologist plan.</description>
    <arm_group_label>Propofol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  IMC &gt; 35 kg m-2&#xD;
&#xD;
          -  Scheduled for laparoscopic bariatric surgery&#xD;
&#xD;
          -  ASA I-II patients&#xD;
&#xD;
          -  Between 20 and 60 yr of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with allergy to study drugs&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  Heart block greater than first degree&#xD;
&#xD;
          -  Take any drug acting in the central nervous system&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pablo O Sepúlveda, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinica Alemana Universidad del Desarrollo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinica Alemana</name>
      <address>
        <city>Santiago</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 9, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>August 14, 2012</last_update_submitted>
  <last_update_submitted_qc>August 14, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad del Desarrollo</investigator_affiliation>
    <investigator_full_name>Pablo Sepulveda</investigator_full_name>
    <investigator_title>Profesor Asociado Anestesiología</investigator_title>
  </responsible_party>
  <keyword>anaesthetics iv</keyword>
  <keyword>propofol</keyword>
  <keyword>pharmacokinetics</keyword>
  <keyword>pharmacodynamic</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propofol</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/NCT01665079
org study id: Propofol TCI obese
nct id: NCT01665079
lead sponsor: 
has dmc: Yes
The aim of this study is to characterize the Pharmacokinetic/Pharmacodynamic relationship of
      a single bolus dose of propofol in obese patients and to extract a time to peak effect
      (t-peak) from the estimated model parameters.
Target controlled infusion (TCI) is a technique to administer intravenous drugs that allows
      rapid achievement and maintenance of predetermined drug concentrations, either in plasma (Cp)
      or at the site of effect (Ce).

      To characterize the time profile of propofol effect an additional parameter, the
      equilibration half time between plasma and effect site (T1/2keo) needs to be incorporated in
      the pharmacokinetic (PK) model.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Profile of Pharmacokinetic and Pharmacodynamic of an induction bolus dose of propofol in obese patients.
time frame: 1, 2, 3, 5, 7 and 10 minutes after the initial bolus dose or until BIS > 75
description: Pharmacokinetic parameters (V1, V2, V3, CL, Q)
Pharmacodynamic parameters (E0, Emax, C50, Gamma, t1/2Ke0, T peak )
arm group label: Propofol
arm group type: Experimental
description: 14 obese patients(IMC>35 kg m-2) scheduled for laparoscopic bariatric surgery
intervention type: Drug
intervention name: Propofol
description: Propofol was administered by plasma TCI and a bolus dose was given by setting the initial plasma target between 12-16 μg/ml according to the anesthesiologist criteria. The protocol target range was selected based on previous experience using this model in the obese. After the patients reached this target, propofol infusion was stopped until the patients woke up (BIS>75). No other drugs were given during this period. Facemask ventilation was assisted only if necessary to maintain SpO2 > 90%. BIS data and propofol infusion data were automatically recorded every five seconds using the AnestFusor© program. Arterial blood samples of 4 ml for propofol assays were collected at 1, 2, 3, 5, 7 and 10 minutes after the initial bolus dose or until BIS > 75. After the patient woke up the study was considered finished and propofol infusion was restarted according to the anesthesiologist plan.
arm group label: Propofol
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pablo O Sepúlveda, MD
role: Principal Investigator
affiliation: Clinica Alemana Universidad del Desarrollo
facility: 
country: Chile
responsible party type: Principal Investigator
investigator affiliation: Universidad del Desarrollo
investigator full name: Pablo Sepulveda
investigator title: Profesor Asociado Anestesiología
mesh term: Propofol