<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/NCT02244515</url>
  </required_header>
  <id_info>
    <org_study_id>ED cerebral palsy</org_study_id>
    <nct_id>NCT02244515</nct_id>
  </id_info>
  <brief_title>Consequence of Dexmedetomidine on Emergence Deliruim After Sevoflurane Anesthesia in Children With Cerebral Palsy</brief_title>
  <official_title>Consequence of Dexmedetomidine on Emergence Deliruim After Sevoflurane Anesthesia in Children With Cerebral Palsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jin Ni</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangzhou Women and Children's Medical Center</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether dexmedetomidine is effective in the&#xD;
      treatment of emergence deliruim after sevoflurane anesthesia in children with cerebral palsy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>June 2014</start_date>
  <primary_completion_date type="Actual">September 2014</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>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pediatric anesthesia emergence delirium (PAED) scale</measure>
    <time_frame>during stay in postanesthesia care unit</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart rate</measure>
    <time_frame>during surgical procedures</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>systolic blood pressure</measure>
    <time_frame>during surgical procedures</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>diastolic blood pressure</measure>
    <time_frame>during surgical procedures</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Emergence Deliruim; Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Five minutes prior to the commencement of the surgical procedure, Group D participants were administered 10 ml NaCI 0.9%.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Five minutes prior to the commencement of the surgical procedure, Group D participants were administered dexmedetomidine 0.5μg•kg-1 diluted in 10 ml NaCI 0.9%</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dexmedetomidine</intervention_name>
    <description>dexmedetomidine 0.5μg•kg-1 diluted in 10 ml NaCI 0.9%</description>
    <arm_group_label>Group D</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Non-quadriplegic (mono-,di-, hemiplegic) children with CP that are scheduled for elective&#xD;
        Achilles-tendon lengthening procedure Guangzhou Women and Children's Medical Center,&#xD;
        Guangzhou, China, with American Society of Anesthesiologists (ASA) physical status I or II.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants that displayed symptoms of sinus bradycardia and atrio-ventricular block,&#xD;
        non-communicative severe developmental delay, seizure disorders, and treatment with seizure&#xD;
        medications&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>September 18, 2014</last_update_submitted>
  <last_update_submitted_qc>September 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Guangzhou Women and Children's Medical Center</investigator_affiliation>
    <investigator_full_name>Jin Ni</investigator_full_name>
    <investigator_title>Vice-administrator of Department of Anesthesiology</investigator_title>
  </responsible_party>
  <keyword>children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Palsy</mesh_term>
  </condition_browse>
  <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/NCT02244515
org study id: ED cerebral palsy
nct id: NCT02244515
lead sponsor: 
The purpose of this study is to determine whether dexmedetomidine is effective in the
      treatment of emergence deliruim after sevoflurane anesthesia in children with cerebral palsy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
measure: pediatric anesthesia emergence delirium (PAED) scale
time frame: during stay in postanesthesia care unit
measure: Heart rate
time frame: during surgical procedures
measure: systolic blood pressure
time frame: during surgical procedures
measure: diastolic blood pressure
time frame: during surgical procedures
arm group label: Group C
arm group type: Placebo Comparator
description: Five minutes prior to the commencement of the surgical procedure, Group D participants were administered 10 ml NaCI 0.9%.
arm group label: Group D
arm group type: Experimental
description: Five minutes prior to the commencement of the surgical procedure, Group D participants were administered dexmedetomidine 0.5μg•kg-1 diluted in 10 ml NaCI 0.9%
intervention type: Drug
intervention name: dexmedetomidine
description: dexmedetomidine 0.5μg•kg-1 diluted in 10 ml NaCI 0.9%
arm group label: Group D
criteria: 
gender: All
minimum age: 2 Years
maximum age: 12 Years
healthy volunteers: No
responsible party type: Sponsor-Investigator
investigator affiliation: Guangzhou Women and Children's Medical Center
investigator full name: Jin Ni
investigator title: Vice-administrator of Department of Anesthesiology
mesh term: Cerebral Palsy
mesh term: Dexmedetomidine