<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/NCT01695486</url>
  </required_header>
  <id_info>
    <org_study_id>11-4778-BO</org_study_id>
    <nct_id>NCT01695486</nct_id>
  </id_info>
  <brief_title>Sedation Monitoring During Open Muscle Biopsy in Children</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Essen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Essen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare sedation monitoring by bispectral index and comfort&#xD;
      score during open muscle biopsies in children.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</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>
  <enrollment type="Actual">30</enrollment>
  <condition>Sedation Monitoring in Children</condition>
  <eligibility>
    <study_pop>
      <textblock>
        children aged 1-18 years undergoing open muscle biopsy as diagnostic procedure&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  infants, children, adolescents undergoing open muscle biopsy as diagnostic procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  missing caregiver or patient consent&#xD;
&#xD;
          -  intolerance of sedative agents in patients´medical history&#xD;
&#xD;
          -  structural brain abnormalities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eva Tschiedel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Essen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Essen</city>
        <state>NRW</state>
        <zip>45122</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>September 15, 2014</last_update_submitted>
  <last_update_submitted_qc>September 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Essen</investigator_affiliation>
    <investigator_full_name>Eva Tschiedel</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>BIS</keyword>
  <keyword>Comfort</keyword>
  <keyword>open muscle biopsy</keyword>
  <!-- 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/NCT01695486
org study id: 11-4778-BO
nct id: NCT01695486
lead sponsor: 
has dmc: No
The purpose of this study is to compare sedation monitoring by bispectral index and comfort
      score during open muscle biopsies in children.
observational model: Case-Only
time perspective: Prospective
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Months
maximum age: 18 Years
healthy volunteers: No
last name: Eva Tschiedel, MD
role: Principal Investigator
affiliation: University Hospital, Essen
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Essen
investigator full name: Eva Tschiedel
investigator title: MD