<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/NCT03262090</url>
  </required_header>
  <id_info>
    <org_study_id>YShe</org_study_id>
    <nct_id>NCT03262090</nct_id>
  </id_info>
  <brief_title>Effect of Dexmedetomidine on the Prevention of Emergence Agitation in Children Undergoing Day Surgery</brief_title>
  <official_title>Efficacy of Different Doses of Dexmedetomidine on the Prevention of Emergence Agitation in Children Undergoing Day Surgery With Desoflurane Anesthesia</official_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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Emergence agitation/delirium (EA/ED) is a common complication in pediatric surgery patients,&#xD;
      which increases the risk of developing postoperative airway obstruction and respiratory&#xD;
      depression. In infants, there is a high incidence of emergence agitation (EA) after&#xD;
      desoflurane anesthesia. The aim of the present preliminary study was to determine the safety&#xD;
      and efficacy of of intraoperative infusion of dexmedetomidine (DEX) that would prevent&#xD;
      postoperative EA and ED in children undergoing day surgery with desoflurane anesthesia&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      subjects who underwent day surgery were stratified into two age groups as follows: low to 3&#xD;
      years group, and 3-12 years group. Then they were randomly assigned to receive one of six&#xD;
      doses of intravenous dexmedetomidine: 0, 0.2, 0.4, 0.6, 0.8 ,1.0ug/kg before skin incision.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 18, 2017</start_date>
  <completion_date type="Actual">May 21, 2019</completion_date>
  <primary_completion_date type="Actual">May 15, 2019</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>The aim of the present preliminary study was to determine the safety and efficacy of of intraoperative infusion of dexmedetomidine (DEX) that would prevent postoperative EA and ED in children undergoing day surgery with desoflurane anesthesia. Subjects who underwent day surgery were stratified into two age groups as follows: low to 3 years, and 3-9 years. Then they were randomly assigned to receive one of six doses of intravenous dexmedetomidine: 0,0.2, 0.4, 0.6, 0.8 ,1.0ug/kg before skin incision.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of emergence agitation at different time interval after emergence</measure>
    <time_frame>at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence</time_frame>
    <description>emergence agitation was evaluated by five-point scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>sedation scales at different time interval after emergence</measure>
    <time_frame>at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence</time_frame>
    <description>sedation was evaluated by MOAA/S scores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain scale at different time interval after emergence</measure>
    <time_frame>at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence</time_frame>
    <description>pain scale was evaluated by FLACC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of emergence delirium at different time interval after emergence</measure>
    <time_frame>at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence</time_frame>
    <description>emergence delirium was evaluated by five-point scale</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">389</enrollment>
  <condition>Ambulatory Surgical Procedures</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects were randomly assigned to receive saline before skin incision</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.2ug/kg dexmedetomidine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects were randomly assigned to receive 0.2ug/kg intravenous dexmedetomidine before skin incision</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.4ug/kg dexmedetomidine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects were randomly assigned to receive 0.4ug/kg intravenous dexmedetomidine before skin incision</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.6ug/kg dexmedetomidine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects were randomly assigned to receive 0.6ug/kg intravenous dexmedetomidine before skin incision</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.8ug/kg dexmedetomidine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects were randomly assigned to receive 0.8ug/kg intravenous dexmedetomidine before skin incision</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1.0ug/kg dexmedetomidine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects were randomly assigned to receive 1.0ug/kg intravenous dexmedetomidine before skin incision</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.2ug/kg dexmedetomidine</intervention_name>
    <description>subjects were randomly assigned to receive 0.2ug/kg intravenous dexmedetomidine before skin incision</description>
    <arm_group_label>0.2ug/kg dexmedetomidine</arm_group_label>
    <other_name>Age</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.4ug/kg dexmedetomidine</intervention_name>
    <description>subjects were randomly assigned to receive 0.4ug/kg intravenous dexmedetomidine before skin incision</description>
    <arm_group_label>0.4ug/kg dexmedetomidine</arm_group_label>
    <other_name>Age</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.6ug/kg dexmedetomidine</intervention_name>
    <description>subjects were randomly assigned to receive 0.6ug/kg intravenous dexmedetomidine before skin incision</description>
    <arm_group_label>0.6ug/kg dexmedetomidine</arm_group_label>
    <other_name>Age</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.8ug/kg dexmedetomidine</intervention_name>
    <description>subjects were randomly assigned to receive 0.8ug/kg intravenous dexmedetomidine before skin incision</description>
    <arm_group_label>0.8ug/kg dexmedetomidine</arm_group_label>
    <other_name>Age</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>1.0ug/kg dexmedetomidine</intervention_name>
    <description>subjects were randomly assigned to receive 1.0ug/kg intravenous dexmedetomidine before skin incision</description>
    <arm_group_label>1.0ug/kg dexmedetomidine</arm_group_label>
    <other_name>Age</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. patients who undergo elective unilateral inguinal hernia or hydrocele testis day&#xD;
             surgery&#xD;
&#xD;
          2. Patients who are American Society of Anesthesiologists classification I and II&#xD;
&#xD;
          3. Patients who are 4 months through 15 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. children with history of respiratory tract infection 1 week preoperatively. 2. patients&#xD;
        with preoperative liver and/or kidney dysfunction, or with mental abnormalities.&#xD;
&#xD;
        3. patients with any congenital malformation or acquired disease that could increase the&#xD;
        risks of anesthesia and the dose of anesthetics (such as, but not limited to, congenital&#xD;
        heart disease, hydronephrosis, nutrition dysplasia). 4. patients with long-term use of&#xD;
        sedative or analgesic drugs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Months</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xia Zheng, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guangzhou Women and Children's Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Guangzhou Women and Children 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>June 2019</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>June 24, 2019</last_update_submitted>
  <last_update_submitted_qc>June 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2019</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>Ying Jun She, MD</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>Emergence Delirium</keyword>
  <keyword>desoflurane</keyword>
  <keyword>general anesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergence Delirium</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/NCT03262090
org study id: YShe
nct id: NCT03262090
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Emergence agitation/delirium (EA/ED) is a common complication in pediatric surgery patients,
      which increases the risk of developing postoperative airway obstruction and respiratory
      depression. In infants, there is a high incidence of emergence agitation (EA) after
      desoflurane anesthesia. The aim of the present preliminary study was to determine the safety
      and efficacy of of intraoperative infusion of dexmedetomidine (DEX) that would prevent
      postoperative EA and ED in children undergoing day surgery with desoflurane anesthesia
subjects who underwent day surgery were stratified into two age groups as follows: low to 3
      years group, and 3-12 years group. Then they were randomly assigned to receive one of six
      doses of intravenous dexmedetomidine: 0, 0.2, 0.4, 0.6, 0.8 ,1.0ug/kg before skin incision.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The aim of the present preliminary study was to determine the safety and efficacy of of intraoperative infusion of dexmedetomidine (DEX) that would prevent postoperative EA and ED in children undergoing day surgery with desoflurane anesthesia. Subjects who underwent day surgery were stratified into two age groups as follows: low to 3 years, and 3-9 years. Then they were randomly assigned to receive one of six doses of intravenous dexmedetomidine: 0,0.2, 0.4, 0.6, 0.8 ,1.0ug/kg before skin incision.
primary purpose: Prevention
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: incidence of emergence agitation at different time interval after emergence
time frame: at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence
description: emergence agitation was evaluated by five-point scale
measure: sedation scales at different time interval after emergence
time frame: at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence
description: sedation was evaluated by MOAA/S scores
measure: pain scale at different time interval after emergence
time frame: at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence
description: pain scale was evaluated by FLACC
measure: incidence of emergence delirium at different time interval after emergence
time frame: at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence
description: emergence delirium was evaluated by five-point scale
arm group label: control group
arm group type: No Intervention
description: Subjects were randomly assigned to receive saline before skin incision
arm group label: 0.2ug/kg dexmedetomidine
arm group type: Active Comparator
description: Subjects were randomly assigned to receive 0.2ug/kg intravenous dexmedetomidine before skin incision
arm group label: 0.4ug/kg dexmedetomidine
arm group type: Active Comparator
description: Subjects were randomly assigned to receive 0.4ug/kg intravenous dexmedetomidine before skin incision
arm group label: 0.6ug/kg dexmedetomidine
arm group type: Active Comparator
description: Subjects were randomly assigned to receive 0.6ug/kg intravenous dexmedetomidine before skin incision
arm group label: 0.8ug/kg dexmedetomidine
arm group type: Active Comparator
description: Subjects were randomly assigned to receive 0.8ug/kg intravenous dexmedetomidine before skin incision
arm group label: 1.0ug/kg dexmedetomidine
arm group type: Active Comparator
description: Subjects were randomly assigned to receive 1.0ug/kg intravenous dexmedetomidine before skin incision
intervention type: Drug
intervention name: 0.2ug/kg dexmedetomidine
description: subjects were randomly assigned to receive 0.2ug/kg intravenous dexmedetomidine before skin incision
arm group label: 0.2ug/kg dexmedetomidine
other name: Age
intervention type: Drug
intervention name: 0.4ug/kg dexmedetomidine
description: subjects were randomly assigned to receive 0.4ug/kg intravenous dexmedetomidine before skin incision
arm group label: 0.4ug/kg dexmedetomidine
other name: Age
intervention type: Drug
intervention name: 0.6ug/kg dexmedetomidine
description: subjects were randomly assigned to receive 0.6ug/kg intravenous dexmedetomidine before skin incision
arm group label: 0.6ug/kg dexmedetomidine
other name: Age
intervention type: Drug
intervention name: 0.8ug/kg dexmedetomidine
description: subjects were randomly assigned to receive 0.8ug/kg intravenous dexmedetomidine before skin incision
arm group label: 0.8ug/kg dexmedetomidine
other name: Age
intervention type: Drug
intervention name: 1.0ug/kg dexmedetomidine
description: subjects were randomly assigned to receive 1.0ug/kg intravenous dexmedetomidine before skin incision
arm group label: 1.0ug/kg dexmedetomidine
other name: Age
criteria: 
gender: All
minimum age: 4 Months
maximum age: 15 Years
healthy volunteers: No
last name: Xia Zheng, Doctor
role: Principal Investigator
affiliation: Guangzhou Women and Children's Medical Center
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Guangzhou Women and Children's Medical Center
investigator full name: Ying Jun She, MD
investigator title: Dr.
mesh term: Emergence Delirium
mesh term: Dexmedetomidine