<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/NCT03806777</url>
  </required_header>
  <id_info>
    <org_study_id>H18-02794</org_study_id>
    <nct_id>NCT03806777</nct_id>
  </id_info>
  <brief_title>Intra-nasal Dexmedetomidine for Children Undergoing MRI Imaging</brief_title>
  <acronym>DexmedMRI</acronym>
  <official_title>Intra-nasal Dexmedetomidine for Children Undergoing MRI Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>British Columbia Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to assess the use of intranasal dexmedetomidine (IN-dex) as a sole agent in&#xD;
      aiding the successful completion of a MRI scans in children. Dexmedetomidine, a routinely&#xD;
      used anesthetic agent in our institution, has many benefits including sedation with&#xD;
      neuro-protective and respiratory sparing features. We will test its effectiveness in&#xD;
      completing MRI scans in children that would otherwise be given a full general anesthetic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose:&#xD;
&#xD;
      To assess the use of IN-dex as a sole agent in aiding the successful completion of a MRI scan&#xD;
      in children.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      We hypothesize that the optimal dose for IN-dex to produce appropriate sedation for MRI will&#xD;
      be between 1 and 3 mcg/kg. We also hypothesize that this dose will be lower in the older age&#xD;
      group.&#xD;
&#xD;
      Justification:&#xD;
&#xD;
      The dose required for IN-dex to enable safe sedation for MRI scanning as a sole agent is&#xD;
      undetermined at present. This study will enable us to find the optimal dose for effective&#xD;
      sedation for MRI scanning in a range of age groups. This will avoid the need for propofol and&#xD;
      remifentanil general anesthesia (that is the current standard of care) in this group of&#xD;
      patients. Our motivation for avoiding general anesthesia is that there is ongoing concern&#xD;
      that general anesthesia causes long term neurocognitive effects in children. Finally,&#xD;
      identifying a safe yet effective dose of IN-dex, which can be nurse-administered, will also&#xD;
      allow us to improve access to MRI scans that are limited by the access to general anesthesia.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
        1. To determine the dose of IN-dex that, when used as a sole agent, produces minimal to&#xD;
           moderate sedation that is adequate for successful completion of MRI in children with&#xD;
           &gt;90% effectiveness.&#xD;
&#xD;
        2. To explore the logistics of a nurse-administered sedation protocol to increase access to&#xD;
           the MRI.&#xD;
&#xD;
      Research Design:&#xD;
&#xD;
      We propose a dose finding study of IN-dex using the biased coin design (BCD) method in three&#xD;
      different age groups (3 to &lt;8 years, 8 to &lt;12 years, 12 to &lt;19 years). The study specific&#xD;
      interventions will include identification of children appropriate for the study following&#xD;
      detailed assessment using a scoring system developed by our Child Life specialists for use at&#xD;
      their MRI preparation session.&#xD;
&#xD;
      Statistical Analysis:&#xD;
&#xD;
      The dose of IN-Dex that produces mild to moderate sedation in 90% of subjects will be&#xD;
      calculated using the pooled adjacent violators algorithm (PAVA) and bootstrap methods will be&#xD;
      used to calculate the 95% confidence limits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 2019</start_date>
  <completion_date type="Anticipated">October 2020</completion_date>
  <primary_completion_date type="Anticipated">March 2020</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>
    <intervention_model_description>Dose finding</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dose</measure>
    <time_frame>Immediately after completion of the MRI scan.</time_frame>
    <description>The intranasal dexmedetomidine dose in mcg/kg that produces successful completion of MRI scan with acceptable MRI image quality in 90% of individuals (ED 90).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Uninterrupted scans</measure>
    <time_frame>Immediately after completion of the MRI scan.</time_frame>
    <description>Total number of scans that were able to be completed without interruptions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respirator support</measure>
    <time_frame>During MRI scan</time_frame>
    <description>Total number of occurrences of respiratory support</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>During MRI scan</time_frame>
    <description>Occurrence of haemodynamic disturbance (bradycardia: absolute heart rate ≤ 40 bpm, hypertension: relative mean arterial pressure ≥ 50% baseline, hypotension: relative mean arterial pressure ≤ 50% baseline)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>modified Yale Preoperative Anxiety Scale (mYPAS)</measure>
    <time_frame>Immediately before administration of intranasal dexmedetomidine</time_frame>
    <description>Pre-procedure mYPAS score. The scale is a total summed score (4-22) of 5 areas; Activity (1-4), Vocalizations (1-6), Emotional expressivity (1-4), state of apparent arousal (1-4), and use of parents (1-4). A lower score represents a lower level of anxiety.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>MRI Sedation</condition>
  <arm_group>
    <arm_group_label>Intra-nasal dexmedetomidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single dose of dexmedetomidine, determined by a biased coin algorithm (min: 1 mcg/kg; max: 4 mcg/kg or 200mcg), will be delivered intranasally 45min before an MRI scan.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>Highly selective alpha-2 adrenergic agonist with sedative properties.</description>
    <arm_group_label>Intra-nasal dexmedetomidine</arm_group_label>
    <other_name>Precedex</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA 1 or 2&#xD;
&#xD;
          -  Scheduled for elective MRI scan on the general anesthesia list&#xD;
&#xD;
          -  Child Life MRI simulation score of 6-10 (Figure 1)&#xD;
&#xD;
          -  Age 3 - 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Taking existing opioid, sedative, or cannabinoid medication&#xD;
&#xD;
          -  Severe learning disability defined as the inability to follow simple commands&#xD;
&#xD;
          -  Severe Cardiac disease&#xD;
&#xD;
          -  Chronic hypertension&#xD;
&#xD;
          -  Allergy to dexmedetomidine&#xD;
&#xD;
          -  Nasal anatomical abnormality&#xD;
&#xD;
          -  Known or anticipated difficult airway&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Ansermino, FRCA</last_name>
    <role>Principal Investigator</role>
    <affiliation>BC Children's Hospital, Department of Anesthesia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Andrew K Poznikoff, BSc</last_name>
    <phone>604-875-2000</phone>
    <phone_ext>1989</phone_ext>
    <email>andrew.poznikoff@cw.bc.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mark Ansermino, FRCA</last_name>
    <phone>604-875-2711</phone>
    <email>mansermino@cw.bc.ca</email>
  </overall_contact_backup>
  <link>
    <url>http://part.bcchr.ca</url>
    <description>Pediatric Anesthesia Research Team website</description>
  </link>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>January 23, 2019</last_update_submitted>
  <last_update_submitted_qc>January 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Mark Ansermino</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>dexmedetomidine</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03806777
org study id: H18-02794
nct id: NCT03806777
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This study aims to assess the use of intranasal dexmedetomidine (IN-dex) as a sole agent in
      aiding the successful completion of a MRI scans in children. Dexmedetomidine, a routinely
      used anesthetic agent in our institution, has many benefits including sedation with
      neuro-protective and respiratory sparing features. We will test its effectiveness in
      completing MRI scans in children that would otherwise be given a full general anesthetic.
Purpose:

      To assess the use of IN-dex as a sole agent in aiding the successful completion of a MRI scan
      in children.

      Hypothesis:

      We hypothesize that the optimal dose for IN-dex to produce appropriate sedation for MRI will
      be between 1 and 3 mcg/kg. We also hypothesize that this dose will be lower in the older age
      group.

      Justification:

      The dose required for IN-dex to enable safe sedation for MRI scanning as a sole agent is
      undetermined at present. This study will enable us to find the optimal dose for effective
      sedation for MRI scanning in a range of age groups. This will avoid the need for propofol and
      remifentanil general anesthesia (that is the current standard of care) in this group of
      patients. Our motivation for avoiding general anesthesia is that there is ongoing concern
      that general anesthesia causes long term neurocognitive effects in children. Finally,
      identifying a safe yet effective dose of IN-dex, which can be nurse-administered, will also
      allow us to improve access to MRI scans that are limited by the access to general anesthesia.

      Objectives:

        1. To determine the dose of IN-dex that, when used as a sole agent, produces minimal to
           moderate sedation that is adequate for successful completion of MRI in children with
           >90% effectiveness.

        2. To explore the logistics of a nurse-administered sedation protocol to increase access to
           the MRI.

      Research Design:

      We propose a dose finding study of IN-dex using the biased coin design (BCD) method in three
      different age groups (3 to <8 years, 8 to <12 years, 12 to <19 years). The study specific
      interventions will include identification of children appropriate for the study following
      detailed assessment using a scoring system developed by our Child Life specialists for use at
      their MRI preparation session.

      Statistical Analysis:

      The dose of IN-Dex that produces mild to moderate sedation in 90% of subjects will be
      calculated using the pooled adjacent violators algorithm (PAVA) and bootstrap methods will be
      used to calculate the 95% confidence limits.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Dose finding
primary purpose: Health Services Research
masking: None (Open Label)
measure: Dose
time frame: Immediately after completion of the MRI scan.
description: The intranasal dexmedetomidine dose in mcg/kg that produces successful completion of MRI scan with acceptable MRI image quality in 90% of individuals (ED 90).
measure: Uninterrupted scans
time frame: Immediately after completion of the MRI scan.
description: Total number of scans that were able to be completed without interruptions
measure: Respirator support
time frame: During MRI scan
description: Total number of occurrences of respiratory support
measure: Adverse events
time frame: During MRI scan
description: Occurrence of haemodynamic disturbance (bradycardia: absolute heart rate ≤ 40 bpm, hypertension: relative mean arterial pressure ≥ 50% baseline, hypotension: relative mean arterial pressure ≤ 50% baseline)
measure: modified Yale Preoperative Anxiety Scale (mYPAS)
time frame: Immediately before administration of intranasal dexmedetomidine
description: Pre-procedure mYPAS score. The scale is a total summed score (4-22) of 5 areas; Activity (1-4), Vocalizations (1-6), Emotional expressivity (1-4), state of apparent arousal (1-4), and use of parents (1-4). A lower score represents a lower level of anxiety.
arm group label: Intra-nasal dexmedetomidine
arm group type: Experimental
description: A single dose of dexmedetomidine, determined by a biased coin algorithm (min: 1 mcg/kg; max: 4 mcg/kg or 200mcg), will be delivered intranasally 45min before an MRI scan.
intervention type: Drug
intervention name: Dexmedetomidine
description: Highly selective alpha-2 adrenergic agonist with sedative properties.
arm group label: Intra-nasal dexmedetomidine
other name: Precedex
criteria: 
gender: All
minimum age: 3 Years
maximum age: 18 Years
healthy volunteers: No
last name: Mark Ansermino, FRCA
role: Principal Investigator
affiliation: BC Children's Hospital, Department of Anesthesia
last name: Andrew K Poznikoff, BSc
phone: 604-875-2000
phone ext: 1989
email: andrew.poznikoff@cw.bc.ca
last name: Mark Ansermino, FRCA
phone: 604-875-2711
email: mansermino@cw.bc.ca
url: http://part.bcchr.ca
description: Pediatric Anesthesia Research Team website
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Mark Ansermino
investigator title: Associate Professor
mesh term: Dexmedetomidine
sharing ipd: Undecided