<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/NCT02222636</url>
  </required_header>
  <id_info>
    <org_study_id>Sedation wei</org_study_id>
    <nct_id>NCT02222636</nct_id>
  </id_info>
  <brief_title>The Clinical Research of Intranasal Dexmedetomidine Used in Plastic Surgery of Children</brief_title>
  <official_title>The Clinical Research of Intranasal Dexmedetomidine Used in Plastic Surgery of Children : A Single Center ,Randomized ,Double-blinded, Controlled Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xijing Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xijing Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to explore the optimal protocol for dexmedetomidine used in&#xD;
      children during perioperative period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">August 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sedation-Agitation Scale</measure>
    <time_frame>The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The pediatric anesthesia emergence delirium scale</measure>
    <time_frame>The moment of entering operating room,and from discontinuation of inhalational anesthetics to the moment of patient's consciousness recovery,an expected average of 1 hour</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Anesthesia induction time</measure>
    <time_frame>From beginning of inhalating anesthetics to the moment of intubation</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Anesthesia maintenance time</measure>
    <time_frame>From the moment of intubation to the discontinuation of inhalational anesthestics</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Recovery time</measure>
    <time_frame>From discontinuation of inhalational anesthestics to the moment of patient's consciousness recovery, an expected average of 1 hour</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in blood pressure during anesthesia</measure>
    <time_frame>The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in heart rate during anesthesia</measure>
    <time_frame>The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in respiratory rate during anesthesia</measure>
    <time_frame>The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The alveolar concentration of inhalational anesthetics</measure>
    <time_frame>the moment of anesthesia induction,the moment of intubation,before cutting skin</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>The Efficacy and Safety of Intranasal Dexmedetomidine</condition>
  <arm_group>
    <arm_group_label>Group 1,Normal saline,1 milliliter</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients will be assigned to receive intranasal normal saline 1 milliliter</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2,dexmedetomidine 1μg.kg-1,1 milliliter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be assigned to receive intranasal dexmedetomidine( 1μg.kg-1) 1 milliliter</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3,dexmedetomidine 2μg.kg-1,1 milliliter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be assigned to receive intranasal dexmedetomidine( 2μg.kg-1 )1 milliliter</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline,1 milliliter</intervention_name>
    <description>Normal saline,1 milliliter, 20 minutes before anaesthetic induction</description>
    <arm_group_label>Group 1,Normal saline,1 milliliter</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine 1 μg.kg-1,1 milliliter</intervention_name>
    <description>Dexmedetomidine 1 μg.kg-1,1 milliliter,20 minutes before anesthesia induction</description>
    <arm_group_label>Group 2,dexmedetomidine 1μg.kg-1,1 milliliter</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine 2μg.kg-1,1 milliliter</intervention_name>
    <description>Dexmedetomidine 2μg.kg-1,1 milliliter,20 minutes before anesthesia induction</description>
    <arm_group_label>Group 3,dexmedetomidine 2μg.kg-1,1 milliliter</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anesthesia induction, 8% sevoflurane</intervention_name>
    <description>Inhalation induction with 8% sevoflurane</description>
    <arm_group_label>Group 1,Normal saline,1 milliliter</arm_group_label>
    <arm_group_label>Group 2,dexmedetomidine 1μg.kg-1,1 milliliter</arm_group_label>
    <arm_group_label>Group 3,dexmedetomidine 2μg.kg-1,1 milliliter</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anesthesia maintenance, 2%~3% sevoflurane,fentanyl</intervention_name>
    <description>2%~3% sevoflurane,inhalation. fentanyl,2μg.kg-1.min-1,intravenous infusion</description>
    <arm_group_label>Group 1,Normal saline,1 milliliter</arm_group_label>
    <arm_group_label>Group 2,dexmedetomidine 1μg.kg-1,1 milliliter</arm_group_label>
    <arm_group_label>Group 3,dexmedetomidine 2μg.kg-1,1 milliliter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent.&#xD;
&#xD;
          -  Elective cleft lip and cleft palate repair surgery&#xD;
&#xD;
          -  American Society of Anesthesiologists class I&#xD;
&#xD;
          -  Aged between 6 months and 7 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suspected or confirmed difficult airway&#xD;
&#xD;
          -  History of upper respiratory tract infection with 1 month&#xD;
&#xD;
          -  Combined with congenital heart disease&#xD;
&#xD;
          -  Allergic to investigational products or with other contraindication&#xD;
&#xD;
          -  Growth retardation or dysgnosia&#xD;
&#xD;
          -  Central nervous system disease&#xD;
&#xD;
          -  Serious infection&#xD;
&#xD;
          -  Serious heart,brain,liver,kidney, pulmonary, and endocrine disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>August 19, 2014</last_update_submitted>
  <last_update_submitted_qc>August 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Xijing Hospital</investigator_affiliation>
    <investigator_full_name>wangqiang</investigator_full_name>
    <investigator_title>department of anesthesijology</investigator_title>
  </responsible_party>
  <keyword>The efficacy and safety of intranasal dexmedetomidine</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Dexmedetomidine</mesh_term>
    <mesh_term>Anesthetics</mesh_term>
    <mesh_term>Sevoflurane</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/NCT02222636
org study id: Sedation wei
nct id: NCT02222636
lead sponsor: 
has dmc: Yes
The purpose of this study is to explore the optimal protocol for dexmedetomidine used in
      children during perioperative period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Sedation-Agitation Scale
time frame: The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction
measure: The pediatric anesthesia emergence delirium scale
time frame: The moment of entering operating room,and from discontinuation of inhalational anesthetics to the moment of patient's consciousness recovery,an expected average of 1 hour
measure: Anesthesia induction time
time frame: From beginning of inhalating anesthetics to the moment of intubation
measure: Anesthesia maintenance time
time frame: From the moment of intubation to the discontinuation of inhalational anesthestics
measure: Recovery time
time frame: From discontinuation of inhalational anesthestics to the moment of patient's consciousness recovery, an expected average of 1 hour
measure: Change from baseline in blood pressure during anesthesia
time frame: The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction
measure: Change from baseline in heart rate during anesthesia
time frame: The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction
measure: Change from baseline in respiratory rate during anesthesia
time frame: The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction
measure: The alveolar concentration of inhalational anesthetics
time frame: the moment of anesthesia induction,the moment of intubation,before cutting skin
arm group label: Group 1,Normal saline,1 milliliter
arm group type: Placebo Comparator
description: Patients will be assigned to receive intranasal normal saline 1 milliliter
arm group label: Group 2,dexmedetomidine 1μg.kg-1,1 milliliter
arm group type: Experimental
description: Patients will be assigned to receive intranasal dexmedetomidine( 1μg.kg-1) 1 milliliter
arm group label: Group 3,dexmedetomidine 2μg.kg-1,1 milliliter
arm group type: Experimental
description: Patients will be assigned to receive intranasal dexmedetomidine( 2μg.kg-1 )1 milliliter
intervention type: Drug
intervention name: Normal saline,1 milliliter
description: Normal saline,1 milliliter, 20 minutes before anaesthetic induction
arm group label: Group 1,Normal saline,1 milliliter
intervention type: Drug
intervention name: Dexmedetomidine 1 μg.kg-1,1 milliliter
description: Dexmedetomidine 1 μg.kg-1,1 milliliter,20 minutes before anesthesia induction
arm group label: Group 2,dexmedetomidine 1μg.kg-1,1 milliliter
intervention type: Drug
intervention name: Dexmedetomidine 2μg.kg-1,1 milliliter
description: Dexmedetomidine 2μg.kg-1,1 milliliter,20 minutes before anesthesia induction
arm group label: Group 3,dexmedetomidine 2μg.kg-1,1 milliliter
intervention type: Drug
intervention name: Anesthesia induction, 8% sevoflurane
description: Inhalation induction with 8% sevoflurane
arm group label: Group 1,Normal saline,1 milliliter
arm group label: Group 2,dexmedetomidine 1μg.kg-1,1 milliliter
arm group label: Group 3,dexmedetomidine 2μg.kg-1,1 milliliter
intervention type: Drug
intervention name: Anesthesia maintenance, 2%~3% sevoflurane,fentanyl
description: 2%~3% sevoflurane,inhalation. fentanyl,2μg.kg-1.min-1,intravenous infusion
arm group label: Group 1,Normal saline,1 milliliter
arm group label: Group 2,dexmedetomidine 1μg.kg-1,1 milliliter
arm group label: Group 3,dexmedetomidine 2μg.kg-1,1 milliliter
criteria: 
gender: All
minimum age: 6 Months
maximum age: 7 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Xijing Hospital
investigator full name: wangqiang
investigator title: department of anesthesijology
mesh term: Fentanyl
mesh term: Dexmedetomidine
mesh term: Anesthetics
mesh term: Sevoflurane