<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/NCT04455776</url>
  </required_header>
  <id_info>
    <org_study_id>CHUB_PEDIRM</org_study_id>
    <nct_id>NCT04455776</nct_id>
  </id_info>
  <brief_title>Safety Evaluation of Propofol Sedation for Magnetic Resonance Imaging in Pediatric Patients</brief_title>
  <official_title>Incidence of Adverse Events During Propofol Sedation for Magnetic Resonance Imaging in Pediatric Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brugmann University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brugmann 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 is often used for sedation in children undergoing magnetic resonance imaging. The&#xD;
      investigators will perform a chart review of 4 month of activity (about 100 cases) and review&#xD;
      the incidence and severity of adverse events of this sedation technique.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Magnetic resonance imaging in children, especially under 6 years of age, is often performed&#xD;
      under sedation. Propofol is a common drug used in this settings. In our institution, sedation&#xD;
      is most often done by a propofol bolus of 2-5 mg/kg in order to reach a deep level of&#xD;
      sedation as defined by Coté et al. If judged necessary by the attending anaesthesiologist, a&#xD;
      additional propofol bolus of 0.5-1 mg/kg may be given. For longer lasting exams, the&#xD;
      attending anaesthesiologist can chose to use a continuous infusion of propofol. The&#xD;
      investigators will review the charts of 4 month of magnetic resonance imaging, which will&#xD;
      give us a cohort of about 100 patients. Baseline characteristics, detailed sedation technique&#xD;
      used will be recorded. Adverse events defined as:&#xD;
&#xD;
        -  Oxygen desaturation measured by transcutaneous oximetry SpO2≤94%&#xD;
&#xD;
        -  hypercapnia measure by end-tidal CO2 &gt;45 mm Hg&#xD;
&#xD;
        -  movement of the patient&#xD;
&#xD;
      Assuming a non-normal distribution (tested by a Kolmogorov-Smirnov test), variables will be&#xD;
      reported as median and interquartile range. Statistical tests will be done by non-parametric&#xD;
      tests, Mann Whitney U. Non continuous variables will be analyzed by a Chi-square test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 3, 2020</start_date>
  <completion_date type="Actual">July 30, 2020</completion_date>
  <primary_completion_date type="Actual">July 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Hypoxemia</measure>
    <time_frame>90 minutes</time_frame>
    <description>Arterial desaturation defined as number of episodes with an SpO2≤94%</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hypercapnia</measure>
    <time_frame>90 minutes</time_frame>
    <description>Hypercapnia, defined as number of episodes with an ETCO2 &gt; 45 mm HG</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Movements</measure>
    <time_frame>90 minutes</time_frame>
    <description>Number of patient movements interfering with the MRI exam</description>
  </primary_outcome>
  <enrollment type="Actual">99</enrollment>
  <condition>Multiparametric Magnetic Resonance Imaging</condition>
  <condition>Propofol Adverse Reaction</condition>
  <condition>Sedation Complication</condition>
  <condition>Anesthesia; Adverse Effect</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>Sedation by propofol</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pediatric patients under 16 years undergoing magnetic resonance imaging under propofol&#xD;
        sedation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pediatric patients scheduled for MRI under sedation by an anaesthesiologist&#xD;
&#xD;
          -  Age &lt; 16 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 16 years&#xD;
&#xD;
          -  Sedation performed by a non-anesthesiologist&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>16 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Denis Schmartz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Brugmann</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Universitaire des Enfants Reine Fabiola</name>
      <address>
        <city>Brussels</city>
        <zip>1020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>August 25, 2020</last_update_submitted>
  <last_update_submitted_qc>August 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brugmann University Hospital</investigator_affiliation>
    <investigator_full_name>Denis SCHMARTZ</investigator_full_name>
    <investigator_title>Head of Anesthesiology department</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>No</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/NCT04455776
org study id: CHUB_PEDIRM
nct id: NCT04455776
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Propofol is often used for sedation in children undergoing magnetic resonance imaging. The
      investigators will perform a chart review of 4 month of activity (about 100 cases) and review
      the incidence and severity of adverse events of this sedation technique.
Magnetic resonance imaging in children, especially under 6 years of age, is often performed
      under sedation. Propofol is a common drug used in this settings. In our institution, sedation
      is most often done by a propofol bolus of 2-5 mg/kg in order to reach a deep level of
      sedation as defined by Coté et al. If judged necessary by the attending anaesthesiologist, a
      additional propofol bolus of 0.5-1 mg/kg may be given. For longer lasting exams, the
      attending anaesthesiologist can chose to use a continuous infusion of propofol. The
      investigators will review the charts of 4 month of magnetic resonance imaging, which will
      give us a cohort of about 100 patients. Baseline characteristics, detailed sedation technique
      used will be recorded. Adverse events defined as:

        -  Oxygen desaturation measured by transcutaneous oximetry SpO2≤94%

        -  hypercapnia measure by end-tidal CO2 >45 mm Hg

        -  movement of the patient

      Assuming a non-normal distribution (tested by a Kolmogorov-Smirnov test), variables will be
      reported as median and interquartile range. Statistical tests will be done by non-parametric
      tests, Mann Whitney U. Non continuous variables will be analyzed by a Chi-square test.
observational model: Cohort
time perspective: Retrospective
measure: Hypoxemia
time frame: 90 minutes
description: Arterial desaturation defined as number of episodes with an SpO2≤94%
measure: Hypercapnia
time frame: 90 minutes
description: Hypercapnia, defined as number of episodes with an ETCO2 > 45 mm HG
measure: Movements
time frame: 90 minutes
description: Number of patient movements interfering with the MRI exam
intervention type: Drug
intervention name: Propofol
description: Sedation by propofol
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 16 Years
last name: Denis Schmartz, MD
role: Principal Investigator
affiliation: CHU Brugmann
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Brugmann University Hospital
investigator full name: Denis SCHMARTZ
investigator title: Head of Anesthesiology department
mesh term: Propofol
sharing ipd: No