<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/NCT02187068</url>
  </required_header>
  <id_info>
    <org_study_id>11-142</org_study_id>
    <nct_id>NCT02187068</nct_id>
  </id_info>
  <brief_title>Dexmedetomidine Pharmacokinetics in the Obese</brief_title>
  <official_title>Dexmedetomidine Pharmacokinetics in the Obese</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pontificia Universidad Catolica de Chile</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pontificia Universidad Catolica de Chile</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to characterize, using two different modeling approaches, one based&#xD;
      on purely statistic concept and one using a more mechanistic analysis, the influence of body&#xD;
      weight and composition on the pharmacokinetic of dexmedetomidine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Twenty obese patients and 20 non-obese patients scheduled for elective laparoscopic surgery&#xD;
      will give dexmedetomidine 0.5 μg.kg-1 over 10 minutes and then randomized to either&#xD;
      dexmedetomidine 0.25 mcg.kg-1.h-1 or dexmedetomidine 0.5 mcg.kg-1.h-1 for approximate 2 h&#xD;
      (range 58-320 min). Blood samples will be taken at 2, 5, 10, 15, 20, 30, 45, 60, 90, 120 min&#xD;
      after beginning dexmedetomidine administration, and at 0, 2, 5, 10, 20, 30, 60, 90, 120, 240&#xD;
      and 360 min after stopping infusion. Population pharmacokinetic modeling will be performed&#xD;
      using nonlinear mixed-effects model.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">December 2012</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>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>dexmedetomidine serum concentration</measure>
    <time_frame>During the intraoperative period and 360 min after stopping dexmedetomidine infusion</time_frame>
    <description>A two compartment distribution model with first order elimination was used to describe dexmedetomidine serum concentration. Population parameter estimates were obtained using non-linear mixed effects models</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Dexmedetomidine obese 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 obese patients scheduled for elective laparoscopic surgery were given dexmedetomidine dexmedetomidine 0.5 μg.kg-1 iv over 10 minutes and then dexmedetomidine 0.25 mcg.kg-1.h-1 for approximate 2 h (range 58-320 min). Blood samples were taken at 2, 5, 10, 15, 20, 30, 45, 60, 90, 120 min after beginning dexmedetomidine administration, and at 0, 2, 5, 10, 20, 30, 60, 90, 120, 240 and 360 min after stopping infusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dexmedetomidine obese 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 obese patients scheduled for elective laparoscopic surgery were given dexmedetomidine dexmedetomidine 0.5 μg.kg-1 iv over 10 minutes and then dexmedetomidine 0.5 mcg.kg-1.h-1 for approximate 2 h (range 58-320 min). Blood samples were taken at 2, 5, 10, 15, 20, 30, 45, 60, 90, 120 min after beginning dexmedetomidine administration, and at 0, 2, 5, 10, 20, 30, 60, 90, 120, 240 and 360 min after stopping infusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dexmedetomidine non-obese 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 non-obese patients scheduled for elective laparoscopic surgery were given dexmedetomidine dexmedetomidine 0.5 μg.kg-1 iv over 10 minutes and then dexmedetomidine 0.25 mcg.kg-1.h-1 for approximate 2 h (range 58-320 min). Blood samples were taken at 2, 5, 10, 15, 20, 30, 45, 60, 90, 120 min after beginning dexmedetomidine administration, and at 0, 2, 5, 10, 20, 30, 60, 90, 120, 240 and 360 min after stopping infusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dexmedetomidine non obese 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 non-obese patients scheduled for elective laparoscopic surgery were given dexmedetomidine dexmedetomidine 0.5 μg.kg-1 iv over 10 minutes and then dexmedetomidine 0.5 mcg.kg-1.h-1 for approximate 2 h (range 58-320 min). Blood samples were taken at 2, 5, 10, 15, 20, 30, 45, 60, 90, 120 min after beginning dexmedetomidine administration, and at 0, 2, 5, 10, 20, 30, 60, 90, 120, 240 and 360 min after stopping infusion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>Dexmedetomidine administered intravenously</description>
    <arm_group_label>Dexmedetomidine non obese 2</arm_group_label>
    <arm_group_label>Dexmedetomidine non-obese 1</arm_group_label>
    <arm_group_label>Dexmedetomidine obese 1</arm_group_label>
    <arm_group_label>Dexmedetomidine obese 2</arm_group_label>
    <other_name>Other names:</other_name>
    <other_name>Precedex</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society Anesthesiologist classification I-III patients&#xD;
&#xD;
          -  between 18 and 60 years of age&#xD;
&#xD;
          -  scheduled for elective laparoscopic surgery&#xD;
&#xD;
          -  obese patients with a BMI &gt;35 kg m-2 (20 patients)&#xD;
&#xD;
          -  non-obese patients (BMI 18.5-25 kg m-2)(20 patients)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known allergy to study drugs&#xD;
&#xD;
          -  uncontrolled hypertension&#xD;
&#xD;
          -  heart block greater than first degree&#xD;
&#xD;
          -  those who had taken any drug acting in the central nervous system 24 h before surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luis I Cortínez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Departamento de Anestesiología, Hospital Clínico Pontificia Universidad Católica de Chile</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Clinico Pontificia Universidad Catolica</name>
      <address>
        <city>Santiago</city>
        <state>Región metropolitana</state>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>June 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>July 7, 2014</last_update_submitted>
  <last_update_submitted_qc>July 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Anaesthetics iv</keyword>
  <keyword>Dexmedetomidine</keyword>
  <keyword>Pharmacokinetic</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</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/NCT02187068
org study id: 11-142
nct id: NCT02187068
lead sponsor: 
has dmc: Yes
The aim of this study is to characterize, using two different modeling approaches, one based
      on purely statistic concept and one using a more mechanistic analysis, the influence of body
      weight and composition on the pharmacokinetic of dexmedetomidine.
Twenty obese patients and 20 non-obese patients scheduled for elective laparoscopic surgery
      will give dexmedetomidine 0.5 μg.kg-1 over 10 minutes and then randomized to either
      dexmedetomidine 0.25 mcg.kg-1.h-1 or dexmedetomidine 0.5 mcg.kg-1.h-1 for approximate 2 h
      (range 58-320 min). Blood samples will be taken at 2, 5, 10, 15, 20, 30, 45, 60, 90, 120 min
      after beginning dexmedetomidine administration, and at 0, 2, 5, 10, 20, 30, 60, 90, 120, 240
      and 360 min after stopping infusion. Population pharmacokinetic modeling will be performed
      using nonlinear mixed-effects model.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: dexmedetomidine serum concentration
time frame: During the intraoperative period and 360 min after stopping dexmedetomidine infusion
description: A two compartment distribution model with first order elimination was used to describe dexmedetomidine serum concentration. Population parameter estimates were obtained using non-linear mixed effects models
arm group label: Dexmedetomidine obese 1
arm group type: Experimental
description: 10 obese patients scheduled for elective laparoscopic surgery were given dexmedetomidine dexmedetomidine 0.5 μg.kg-1 iv over 10 minutes and then dexmedetomidine 0.25 mcg.kg-1.h-1 for approximate 2 h (range 58-320 min). Blood samples were taken at 2, 5, 10, 15, 20, 30, 45, 60, 90, 120 min after beginning dexmedetomidine administration, and at 0, 2, 5, 10, 20, 30, 60, 90, 120, 240 and 360 min after stopping infusion.
arm group label: Dexmedetomidine obese 2
arm group type: Experimental
description: 10 obese patients scheduled for elective laparoscopic surgery were given dexmedetomidine dexmedetomidine 0.5 μg.kg-1 iv over 10 minutes and then dexmedetomidine 0.5 mcg.kg-1.h-1 for approximate 2 h (range 58-320 min). Blood samples were taken at 2, 5, 10, 15, 20, 30, 45, 60, 90, 120 min after beginning dexmedetomidine administration, and at 0, 2, 5, 10, 20, 30, 60, 90, 120, 240 and 360 min after stopping infusion.
arm group label: Dexmedetomidine non-obese 1
arm group type: Experimental
description: 10 non-obese patients scheduled for elective laparoscopic surgery were given dexmedetomidine dexmedetomidine 0.5 μg.kg-1 iv over 10 minutes and then dexmedetomidine 0.25 mcg.kg-1.h-1 for approximate 2 h (range 58-320 min). Blood samples were taken at 2, 5, 10, 15, 20, 30, 45, 60, 90, 120 min after beginning dexmedetomidine administration, and at 0, 2, 5, 10, 20, 30, 60, 90, 120, 240 and 360 min after stopping infusion.
arm group label: Dexmedetomidine non obese 2
arm group type: Experimental
description: 10 non-obese patients scheduled for elective laparoscopic surgery were given dexmedetomidine dexmedetomidine 0.5 μg.kg-1 iv over 10 minutes and then dexmedetomidine 0.5 mcg.kg-1.h-1 for approximate 2 h (range 58-320 min). Blood samples were taken at 2, 5, 10, 15, 20, 30, 45, 60, 90, 120 min after beginning dexmedetomidine administration, and at 0, 2, 5, 10, 20, 30, 60, 90, 120, 240 and 360 min after stopping infusion.
intervention type: Drug
intervention name: Dexmedetomidine
description: Dexmedetomidine administered intravenously
arm group label: Dexmedetomidine non obese 2
arm group label: Dexmedetomidine non-obese 1
arm group label: Dexmedetomidine obese 1
arm group label: Dexmedetomidine obese 2
other name: Other names:
other name: Precedex
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Luis I Cortínez, MD
role: Principal Investigator
affiliation: Departamento de Anestesiología, Hospital Clínico Pontificia Universidad Católica de Chile
facility: 
country: Chile
responsible party type: Sponsor
mesh term: Dexmedetomidine