<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/NCT03283410</url>
  </required_header>
  <id_info>
    <org_study_id>CAEE 41471115.1.0000.5558</org_study_id>
    <nct_id>NCT03283410</nct_id>
  </id_info>
  <brief_title>Determination of Propofol Target Concentration for Young and Elderly by Suppression Rate Analysis</brief_title>
  <official_title>Determination of Propofol Target Concentration for Young and Elderly by Suppression Rate Analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brasilia University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brasilia 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>
      Propofol's dose-response curve is know for the average adult but propofol's plasmatic&#xD;
      concentration under total intravenous anesthesia differences between young and elderly must&#xD;
      be modeled. Adaptative clinical trial (Dixon's Up and Down) for determination of ED95% of&#xD;
      propofol concentration for hypnosis under general anesthesia for young and elderly adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Propofol's dose-response curve is know for the average adult but propofol's plasmatic&#xD;
      concentration under total intravenous anesthesia differences between young and elderly must&#xD;
      be modeled. Method: adaptative clinical trial (Dixon's Up and Down method) for determination&#xD;
      of ED95% of propofol concentration (plasmatic, Marsh model) for hypnosis (BIS ranging from 40&#xD;
      to 60) under general anesthesia for young and elderly adults.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Local problems with BIS monitor, we wont have it anymore.&#xD;
  </why_stopped>
  <start_date type="Actual">January 30, 2017</start_date>
  <completion_date type="Actual">January 30, 2017</completion_date>
  <primary_completion_date type="Actual">January 30, 2017</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>BIS value greater than 60 or lower than 40 during general anesthesia</measure>
    <time_frame>BIS value greater than 60 or lower than 40 during general anesthesia</time_frame>
    <description>BIS value greater than 60 or lower than 40 during general anesthesia</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Single Study Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients will be sequentially allocated in the single study arm. All patients will receive some propofol dose.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>Propofol plasmatic concentration (Marsh)</description>
    <arm_group_label>Single Study Arm</arm_group_label>
    <other_name>Diprivan</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Both sex&#xD;
&#xD;
          -  Between 18-28 or 65-75 years old&#xD;
&#xD;
          -  ASA physical status I or II&#xD;
&#xD;
          -  no pre-anesthetic medications prescribed&#xD;
&#xD;
          -  scheduled for surgery under general anesthesia&#xD;
&#xD;
          -  willing to participate and sign informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications for propofol usage&#xD;
&#xD;
          -  history of neurologic or psychiatric diseases&#xD;
&#xD;
          -  drug abusers&#xD;
&#xD;
          -  users of drugs that alter central nervous system&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  emergency surgeries&#xD;
&#xD;
          -  rapid sequence intubation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gabriel MN Guimaraes, MsC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>May 29, 2015</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>September 12, 2017</last_update_submitted>
  <last_update_submitted_qc>September 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brasilia University Hospital</investigator_affiliation>
    <investigator_full_name>Gabriel Magalhaes Nunes Guimaraes</investigator_full_name>
    <investigator_title>Head of Anesthesiology</investigator_title>
  </responsible_party>
  <keyword>propofol</keyword>
  <keyword>dose-response</keyword>
  <keyword>elderly</keyword>
  <keyword>young adults</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/NCT03283410
org study id: CAEE 41471115.1.0000.5558
nct id: NCT03283410
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Propofol's dose-response curve is know for the average adult but propofol's plasmatic
      concentration under total intravenous anesthesia differences between young and elderly must
      be modeled. Adaptative clinical trial (Dixon's Up and Down) for determination of ED95% of
      propofol concentration for hypnosis under general anesthesia for young and elderly adults.
Propofol's dose-response curve is know for the average adult but propofol's plasmatic
      concentration under total intravenous anesthesia differences between young and elderly must
      be modeled. Method: adaptative clinical trial (Dixon's Up and Down method) for determination
      of ED95% of propofol concentration (plasmatic, Marsh model) for hypnosis (BIS ranging from 40
      to 60) under general anesthesia for young and elderly adults.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: BIS value greater than 60 or lower than 40 during general anesthesia
time frame: BIS value greater than 60 or lower than 40 during general anesthesia
description: BIS value greater than 60 or lower than 40 during general anesthesia
arm group label: Single Study Arm
arm group type: Experimental
description: All patients will be sequentially allocated in the single study arm. All patients will receive some propofol dose.
intervention type: Drug
intervention name: Propofol
description: Propofol plasmatic concentration (Marsh)
arm group label: Single Study Arm
other name: Diprivan
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gabriel MN Guimaraes, MsC
role: Principal Investigator
affiliation: Professor
responsible party type: Principal Investigator
investigator affiliation: Brasilia University Hospital
investigator full name: Gabriel Magalhaes Nunes Guimaraes
investigator title: Head of Anesthesiology
mesh term: Propofol