<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/NCT03807011</url>
  </required_header>
  <id_info>
    <org_study_id>YUMC 2017-04-071</org_study_id>
    <nct_id>NCT03807011</nct_id>
  </id_info>
  <brief_title>Emergence Agitation in Pediatric Strabismus Surgery</brief_title>
  <official_title>The Effects of Remifentanil and Fentanyl on Emergence Agitation in Pediatric Strabismus Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yeungnam University College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yeungnam University College of Medicine</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was performed to assess the effects of continuous remifentanil infusion and single&#xD;
      bolus administration of fentanyl on the incidence of emergence agitation in pediatrics&#xD;
      undergoing strabismus surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 7, 2017</start_date>
  <completion_date type="Actual">October 5, 2018</completion_date>
  <primary_completion_date type="Actual">October 5, 2018</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of postoperative agitation</measure>
    <time_frame>5 minutes in the recovery room</time_frame>
    <description>0=none; 1=occur</description>
  </primary_outcome>
  <primary_outcome>
    <measure>incidence of postoperative agitation</measure>
    <time_frame>30 minutes in the recovery room</time_frame>
    <description>0=none; 1=occur</description>
  </primary_outcome>
  <primary_outcome>
    <measure>severity of postoperative agitation</measure>
    <time_frame>5 minutes in the recovery room</time_frame>
    <description>Four-point agitation scale (0=calm; 1=not calm but could easily become calmed; 3=not easily calmed, moderately agitated and restless; 4=combative, excited, or disoriented)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>severity of postoperative agitation</measure>
    <time_frame>30 minutes in the recovery room</time_frame>
    <description>Four-point agitation scale (0=calm; 1=not calm but could easily become calmed; 3=not easily calmed, moderately agitated and restless; 4=combative, excited, or disoriented)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Emergence Agitation</condition>
  <arm_group>
    <arm_group_label>fentanyl</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A bolus dose of fentanyl 2 μg/kg was administered intravenously at anesthetic induction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>remifentanil</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Remifentanil was continuously infused at a rate of 0.2 μg/kg/min from anesthetic induction to the end of surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>fentanyl group</intervention_name>
    <description>fentanyl 2 μg/kg</description>
    <arm_group_label>fentanyl</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>remifentanil group</intervention_name>
    <description>remifentanil 0.2 μg/kg/min</description>
    <arm_group_label>remifentanil</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients undergoing elective subumbilical surgery,&#xD;
&#xD;
          -  physical status was American Society of Anesthesiologists (ASA) class 1 or 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of airway problem,&#xD;
&#xD;
          -  upper respiratory tract infection within 2 weeks,&#xD;
&#xD;
          -  developmental delay,&#xD;
&#xD;
          -  neurological or psychological disease,&#xD;
&#xD;
          -  history of allergy to the drugs in our protocol were excluded in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Eun kyung Choi</name>
      <address>
        <city>Daegu</city>
        <state>Korea (the Republic Of)</state>
        <zip>41944</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yeungnam University Hospital</name>
      <address>
        <city>Daegu</city>
        <state>Nam-gu, Daegu</state>
        <zip>42415</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>January 20, 2019</last_update_submitted>
  <last_update_submitted_qc>January 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yeungnam University College of Medicine</investigator_affiliation>
    <investigator_full_name>Eun Kyung Choi</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Emergence Agitation</keyword>
  <keyword>fentanyl</keyword>
  <keyword>remifentanil</keyword>
  <keyword>children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psychomotor Agitation</mesh_term>
    <mesh_term>Strabismus</mesh_term>
    <mesh_term>Emergence Delirium</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Remifentanil</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/NCT03807011
org study id: YUMC 2017-04-071
nct id: NCT03807011
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study was performed to assess the effects of continuous remifentanil infusion and single
      bolus administration of fentanyl on the incidence of emergence agitation in pediatrics
      undergoing strabismus surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: incidence of postoperative agitation
time frame: 5 minutes in the recovery room
description: 0=none; 1=occur
measure: incidence of postoperative agitation
time frame: 30 minutes in the recovery room
description: 0=none; 1=occur
measure: severity of postoperative agitation
time frame: 5 minutes in the recovery room
description: Four-point agitation scale (0=calm; 1=not calm but could easily become calmed; 3=not easily calmed, moderately agitated and restless; 4=combative, excited, or disoriented)
measure: severity of postoperative agitation
time frame: 30 minutes in the recovery room
description: Four-point agitation scale (0=calm; 1=not calm but could easily become calmed; 3=not easily calmed, moderately agitated and restless; 4=combative, excited, or disoriented)
arm group label: fentanyl
arm group type: Active Comparator
description: A bolus dose of fentanyl 2 μg/kg was administered intravenously at anesthetic induction
arm group label: remifentanil
arm group type: Active Comparator
description: Remifentanil was continuously infused at a rate of 0.2 μg/kg/min from anesthetic induction to the end of surgery
intervention type: Drug
intervention name: fentanyl group
description: fentanyl 2 μg/kg
arm group label: fentanyl
intervention type: Drug
intervention name: remifentanil group
description: remifentanil 0.2 μg/kg/min
arm group label: remifentanil
criteria: 
gender: All
minimum age: 2 Years
maximum age: 8 Years
healthy volunteers: No
facility: 
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Yeungnam University College of Medicine
investigator full name: Eun Kyung Choi
investigator title: Professor
mesh term: Psychomotor Agitation
mesh term: Strabismus
mesh term: Emergence Delirium
mesh term: Fentanyl
mesh term: Remifentanil