<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/NCT02253199</url>
  </required_header>
  <id_info>
    <org_study_id>WZhang-02</org_study_id>
    <nct_id>NCT02253199</nct_id>
  </id_info>
  <brief_title>The Effect of Age on the Median Effective Dose (ED50) of Intranasal Dexmedetomidine for Rescue Sedation Following Failed Sedation With Oral Chloral Hydrate During Magnetic Resonance Imaging</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangzhou Women and Children's Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangzhou Women and Children's Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Increasing evidences suggest that dexmedetomidine Pharmacokinetic are different in children.&#xD;
      We performed a up-down sequential allocation study to determine the ED50 for rescue sedation&#xD;
      following sedation failures in children and to investigate age-related differences in the&#xD;
      rescue sedation with dexmedetomidine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      About 150 children who were not adequately sedated ( no evidence of adequate sedation within&#xD;
      30 min after administration of Initial dose of chloral hydrate) were stratified into four age&#xD;
      groups as follows: 1-6 month, 7 -12 month, 13 -24 month, and 25-36 month. The intranasal&#xD;
      dexmedetomidine dose was determined by the success or failure of rescue sedation achieved by&#xD;
      the previous patients, according to Dixon's up-down sequential allocation method. Successful&#xD;
      sedation was defined as a MOAA/S(modified Observer Assessment of Alertness and Sedation) of&#xD;
      between 0 and 3. The EC50 were estimated from the up-and-down sequences using the method of&#xD;
      Dixon and Massey and logistic regression. Patients' sedation status, sedation induction time,&#xD;
      time to Wake up, blood pressure, heart rate, and oxygen saturation were recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>Double (Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The median effect dose of intranasal dexmedetomidine</measure>
    <time_frame>up to 1 hours after MRI scaning</time_frame>
    <description>Sedation status was evaluated by a attending anesthesiologists every 5-10 min with a 6-point sedation scale, which was modified from the Modified Observer Assessment of Alertness and Sedation Scale (MOAA/S).successful sedation was defined as an MOAA/S of between 0 and 3</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>sedation induction time</measure>
    <time_frame>up to 30 min after rescue drug administration</time_frame>
    <description>Successful sedation was defined as an MOAA/S of between 0 and 3, and sedation induction time was defined as the time from rescue drug administration to the onset of satisfactory sedation&#xD;
0 Does not respond to a noxious stimulus&#xD;
Does not respond to mild prodding or shaking&#xD;
Responds only after mild prodding or shaking&#xD;
Responds only after name is called loudly orrepeatedly&#xD;
Lethargic response to name spoken in normal tone&#xD;
Appears asleep, but responds readily to namespoken in normal tone&#xD;
Appears alert and awake, responds readily to namespoken in normal tone</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wake -up time</measure>
    <time_frame>up to 4 hours after rescue drug administration</time_frame>
    <description>Children were classified as awake if the MOAA/S was between 4 and 6. Wake -up time was defined as the time from successful sedation until the time that the child awoke</description>
  </secondary_outcome>
  <other_outcome>
    <measure>heart rate</measure>
    <time_frame>baseline, before and 15 , 60, 75, 90 min after rescue drug administration</time_frame>
    <description>changes in heart rates at the baseline, before and 15 , 60, 75, 90 min after rescue drug administration</description>
  </other_outcome>
  <other_outcome>
    <measure>non-invasive systolic blood pressure</measure>
    <time_frame>baseline, before and 15 , 60, 75, 90 min after rescue drug administration</time_frame>
    <description>changes in the non-invasive systolic blood pressure at the baseline, before and 15 , 30, 60, 75, 90 min after rescue drug administration</description>
  </other_outcome>
  <other_outcome>
    <measure>Oxyhemoglobin desaturation</measure>
    <time_frame>baseline and four hours after rescue medicine administration</time_frame>
    <description>Significant Oxyhemoglobin desaturation was defined as&lt;94%</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Aged</condition>
  <condition>Drug</condition>
  <condition>Dose-Response Relationship</condition>
  <arm_group>
    <arm_group_label>1-6 months (Group 1)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects stratified into four groups according to age: 1-6 months (Group 1), 7-12 months (Group 2),13-24 months (Group 3), 26-36 months (Group 4).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>7-12 months (Group 2)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects stratified into four groups according to age: 1-6 months (Group 1), 7-12 months (Group 2),13-24 months (Group 3), 26-36 months (Group 4).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>13-24 months (Group 3)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects stratified into four groups according to age: 1-6 months (Group 1), 7-12 months (Group 2),13-24 months (Group 3), 26-36 months (Group 4).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>25-36 months (Group 4)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects stratified into four groups according to age: 1-6 months (Group 1), 7-12 months (Group 2),13-24 months (Group 3), 26-36 months (Group 4).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>intranasal dexmedetomidine</intervention_name>
    <description>Children who were not adequately sedated ( no evidence of adequate sedation within 30 min after administration of Initial dose of chloral hydrate) received a bolus of intranasal dexmedetomidine which adjusted by the &quot;Dixon up-and-down method for rescue sedation.&#xD;
The first child received 0.8mcg/Kg of intranasal dexmedetomidine dose (100mcg/ml), and the dose interval was set at 0.1mcg/Kg.</description>
    <arm_group_label>1-6 months (Group 1)</arm_group_label>
    <arm_group_label>13-24 months (Group 3)</arm_group_label>
    <arm_group_label>25-36 months (Group 4)</arm_group_label>
    <arm_group_label>7-12 months (Group 2)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  150 children of ASA physical status I or II, aged between 1 and 36 months, failed&#xD;
             chloral hydrate sedation during MRI scanning,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known allergy or hypersensitive reaction to drugs of this study, Weight greater than&#xD;
             20 kg or less than 4.5 kg, organ dysfunction, pneumonia, acute upper respiratory&#xD;
             airway inflammation, preterm, cardiac arrhythmia and congenital heart disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>36 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Anesthesiology of Guangzhou Women and Children's Medical Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>March 26, 2016</last_update_submitted>
  <last_update_submitted_qc>March 26, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangzhou Women and Children's Medical Center</investigator_affiliation>
    <investigator_full_name>Wenhua Zhang</investigator_full_name>
    <investigator_title>Director, Clinical Resesearch</investigator_title>
  </responsible_party>
  <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/NCT02253199
org study id: WZhang-02
nct id: NCT02253199
lead sponsor: 
has dmc: Yes
Increasing evidences suggest that dexmedetomidine Pharmacokinetic are different in children.
      We performed a up-down sequential allocation study to determine the ED50 for rescue sedation
      following sedation failures in children and to investigate age-related differences in the
      rescue sedation with dexmedetomidine.
About 150 children who were not adequately sedated ( no evidence of adequate sedation within
      30 min after administration of Initial dose of chloral hydrate) were stratified into four age
      groups as follows: 1-6 month, 7 -12 month, 13 -24 month, and 25-36 month. The intranasal
      dexmedetomidine dose was determined by the success or failure of rescue sedation achieved by
      the previous patients, according to Dixon's up-down sequential allocation method. Successful
      sedation was defined as a MOAA/S(modified Observer Assessment of Alertness and Sedation) of
      between 0 and 3. The EC50 were estimated from the up-and-down sequences using the method of
      Dixon and Massey and logistic regression. Patients' sedation status, sedation induction time,
      time to Wake up, blood pressure, heart rate, and oxygen saturation were recorded.
allocation: Non-Randomized
intervention model: Parallel Assignment
masking: Double (Care Provider, Investigator)
measure: The median effect dose of intranasal dexmedetomidine
time frame: up to 1 hours after MRI scaning
description: Sedation status was evaluated by a attending anesthesiologists every 5-10 min with a 6-point sedation scale, which was modified from the Modified Observer Assessment of Alertness and Sedation Scale (MOAA/S).successful sedation was defined as an MOAA/S of between 0 and 3
measure: sedation induction time
time frame: up to 30 min after rescue drug administration
description: Successful sedation was defined as an MOAA/S of between 0 and 3, and sedation induction time was defined as the time from rescue drug administration to the onset of satisfactory sedation
0 Does not respond to a noxious stimulus
Does not respond to mild prodding or shaking
Responds only after mild prodding or shaking
Responds only after name is called loudly orrepeatedly
Lethargic response to name spoken in normal tone
Appears asleep, but responds readily to namespoken in normal tone
Appears alert and awake, responds readily to namespoken in normal tone
measure: Wake -up time
time frame: up to 4 hours after rescue drug administration
description: Children were classified as awake if the MOAA/S was between 4 and 6. Wake -up time was defined as the time from successful sedation until the time that the child awoke
measure: heart rate
time frame: baseline, before and 15 , 60, 75, 90 min after rescue drug administration
description: changes in heart rates at the baseline, before and 15 , 60, 75, 90 min after rescue drug administration
measure: non-invasive systolic blood pressure
time frame: baseline, before and 15 , 60, 75, 90 min after rescue drug administration
description: changes in the non-invasive systolic blood pressure at the baseline, before and 15 , 30, 60, 75, 90 min after rescue drug administration
measure: Oxyhemoglobin desaturation
time frame: baseline and four hours after rescue medicine administration
description: Significant Oxyhemoglobin desaturation was defined as<94%
arm group label: 1-6 months (Group 1)
arm group type: Active Comparator
description: Subjects stratified into four groups according to age: 1-6 months (Group 1), 7-12 months (Group 2),13-24 months (Group 3), 26-36 months (Group 4).
arm group label: 7-12 months (Group 2)
arm group type: Active Comparator
description: Subjects stratified into four groups according to age: 1-6 months (Group 1), 7-12 months (Group 2),13-24 months (Group 3), 26-36 months (Group 4).
arm group label: 13-24 months (Group 3)
arm group type: Active Comparator
description: Subjects stratified into four groups according to age: 1-6 months (Group 1), 7-12 months (Group 2),13-24 months (Group 3), 26-36 months (Group 4).
arm group label: 25-36 months (Group 4)
arm group type: Active Comparator
description: Subjects stratified into four groups according to age: 1-6 months (Group 1), 7-12 months (Group 2),13-24 months (Group 3), 26-36 months (Group 4).
intervention type: Drug
intervention name: intranasal dexmedetomidine
description: Children who were not adequately sedated ( no evidence of adequate sedation within 30 min after administration of Initial dose of chloral hydrate) received a bolus of intranasal dexmedetomidine which adjusted by the "Dixon up-and-down method for rescue sedation.
The first child received 0.8mcg/Kg of intranasal dexmedetomidine dose (100mcg/ml), and the dose interval was set at 0.1mcg/Kg.
arm group label: 1-6 months (Group 1)
arm group label: 13-24 months (Group 3)
arm group label: 25-36 months (Group 4)
arm group label: 7-12 months (Group 2)
criteria: 
gender: All
minimum age: 1 Month
maximum age: 36 Months
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Guangzhou Women and Children's Medical Center
investigator full name: Wenhua Zhang
investigator title: Director, Clinical Resesearch
mesh term: Dexmedetomidine