<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/NCT02239445</url>
  </required_header>
  <id_info>
    <org_study_id>WZhang</org_study_id>
    <nct_id>NCT02239445</nct_id>
  </id_info>
  <brief_title>Intranasal Dexmedetomidine VS Oral Chloral Hydrate for Rescue Sedation 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>
      The purpose of this investigation was to test the hypothesis that intranasal dexmedetomidine&#xD;
      is as effective as second dose of oral chloral hydrate for rescue sedation in infant age&#xD;
      between 1 and 6 months who were not adequately sedated following initial dose of chloral&#xD;
      hydrate.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>Double (Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>successful rescue sedation rate</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 Observer Assessment of Alertness and Sedation Scale (MOAA/S; Table 1).&#xD;
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 2, 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>non-invasive systolic blood pressure</measure>
    <time_frame>baseline, before and 15 , 30, 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>heart rate</measure>
    <time_frame>baseline, before and 15 , 30, 60, 75, 90 min after rescue drug administration</time_frame>
    <description>changes in heart rates 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>3</number_of_arms>
  <enrollment type="Actual">158</enrollment>
  <condition>Administration Related Reaction</condition>
  <condition>Failed Moderate Sedation During Procedure</condition>
  <condition>Chloral Hydrate Adverse Reaction</condition>
  <arm_group>
    <arm_group_label>chloral hydrate group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>chloral hydrate 0.25 mg/kg oral solution diluted with oral syrup to 5 ml and 0.2 mL intranasal placebo (normal saline)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>low dose dexmedetomidine Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group L received intranasal dexmedetomidine at 1mcg/kg and 5 ml oral syrup&#xD;
Undiluted preservative-free dexmedetomidine (AiBeiNing; Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) was prepared in a concentration of 100mcg/ml and dripped into both nostrils using a 1 mL syringe with the child in the Supine position.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>high dose dexmedetomidine group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group H received intranasal dexmedetomidine at 2mcg/kg and 5 ml oral syrup&#xD;
Undiluted preservative-free dexmedetomidine (AiBeiNing; Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) was prepared in a concentration of 100mcg/ml and dripped into both nostrils using a 1 mL syringe with the child in the Supine position.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>chloral hydrate Group</intervention_name>
    <description>chloral hydrate 0.25 mg/kg oral solution diluted with oral syrup to 5 ml and 0.2 mL intranasal placebo (normal saline)</description>
    <arm_group_label>chloral hydrate group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>low dose dexmedetomidine group</intervention_name>
    <description>Group L received intranasal dexmedetomidine at 1mcg/kg and 5 ml oral syrup</description>
    <arm_group_label>low dose dexmedetomidine Group</arm_group_label>
    <other_name>AiBeiNing</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>high dose dexmedetomidine group</intervention_name>
    <description>Group H received intranasal dexmedetomidine at 2mcg/kg and 5 ml oral syrup</description>
    <arm_group_label>high dose dexmedetomidine group</arm_group_label>
    <other_name>AiBeiNing</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  160 children of ASA physical status I or II, aged between 1 and 6 months, failed&#xD;
             chloral hydrate sedation during MRI scanning&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known allergy or hypersensitive reaction to dexmedetomidine or CH, organ dysfunction,&#xD;
             pneumonia, acute upper respiratory airway inflammation, preterm, cardiac arrhythmia or&#xD;
             and congenital heart disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>6 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>
    <facility>
      <name>Guangzhou Women and Children's Medical Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>May 9, 2015</last_update_submitted>
  <last_update_submitted_qc>May 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 12, 2015</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>Bureau of Health of Guangzhou</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
    <mesh_term>Chloral Hydrate</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/NCT02239445
org study id: WZhang
nct id: NCT02239445
lead sponsor: 
has dmc: Yes
The purpose of this investigation was to test the hypothesis that intranasal dexmedetomidine
      is as effective as second dose of oral chloral hydrate for rescue sedation in infant age
      between 1 and 6 months who were not adequately sedated following initial dose of chloral
      hydrate.
allocation: Randomized
intervention model: Parallel Assignment
masking: Double (Care Provider, Investigator)
measure: successful rescue sedation rate
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 Observer Assessment of Alertness and Sedation Scale (MOAA/S; Table 1).
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 2, 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: non-invasive systolic blood pressure
time frame: baseline, before and 15 , 30, 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: heart rate
time frame: baseline, before and 15 , 30, 60, 75, 90 min after rescue drug administration
description: changes in heart rates 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: chloral hydrate group
arm group type: Active Comparator
description: chloral hydrate 0.25 mg/kg oral solution diluted with oral syrup to 5 ml and 0.2 mL intranasal placebo (normal saline)
arm group label: low dose dexmedetomidine Group
arm group type: Experimental
description: Group L received intranasal dexmedetomidine at 1mcg/kg and 5 ml oral syrup
Undiluted preservative-free dexmedetomidine (AiBeiNing; Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) was prepared in a concentration of 100mcg/ml and dripped into both nostrils using a 1 mL syringe with the child in the Supine position.
arm group label: high dose dexmedetomidine group
arm group type: Experimental
description: Group H received intranasal dexmedetomidine at 2mcg/kg and 5 ml oral syrup
Undiluted preservative-free dexmedetomidine (AiBeiNing; Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) was prepared in a concentration of 100mcg/ml and dripped into both nostrils using a 1 mL syringe with the child in the Supine position.
intervention type: Drug
intervention name: chloral hydrate Group
description: chloral hydrate 0.25 mg/kg oral solution diluted with oral syrup to 5 ml and 0.2 mL intranasal placebo (normal saline)
arm group label: chloral hydrate group
intervention type: Drug
intervention name: low dose dexmedetomidine group
description: Group L received intranasal dexmedetomidine at 1mcg/kg and 5 ml oral syrup
arm group label: low dose dexmedetomidine Group
other name: AiBeiNing
intervention type: Drug
intervention name: high dose dexmedetomidine group
description: Group H received intranasal dexmedetomidine at 2mcg/kg and 5 ml oral syrup
arm group label: high dose dexmedetomidine group
other name: AiBeiNing
criteria: 
gender: All
minimum age: 1 Month
maximum age: 6 Months
healthy volunteers: No
facility: 
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Guangzhou Women and Children's Medical Center
investigator full name: Wenhua Zhang
investigator title: Bureau of Health of Guangzhou
mesh term: Dexmedetomidine
mesh term: Chloral Hydrate