xml: <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/NCT06035757</url>
    </required_header>
    <id_info>
      <org_study_id>KUMC2023-05-082</org_study_id>
      <nct_id>NCT06035757</nct_id>
    </id_info>
    <brief_title>The Occurrence of Emergence Agitation in Pediatric Strabismus Surgery</brief_title>
    <official_title>The Effect of Administration of Sugammadex on the Occurrence of Emergence Agitation in Pediatric Strabismus Surgery-prospective Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Konkuk University Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Konkuk University Medical Center</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>
        The present tiral conduted to demonstrate the administration of sugammadex as reversal of&#xD;
        neuromuscular blockade agent reduces the incedence of emergence agitation (EA) comparing to&#xD;
        neostigmine&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        EA is one of the most common postoperative complications in after general anesthesia in&#xD;
        pre-school aged pediatric patients. There are several causes contributed to occurrence of EA&#xD;
        such as postoperative pain, type of surgery and surgical site, hyperthermia or hypothermia.&#xD;
        Some researches showed that the occurrence of EA is associated with patients' anxiety and we&#xD;
        inferred that patients' anxiety after general anesthesia could be related to ability to&#xD;
        breathe. Ability to breathe is highly associated with level of residual neuromuscular&#xD;
        blockade (NMB) after recovery from general anesthesia. We evaluate the Pediatric Anesthesia&#xD;
        Emergence Delirium (PAED) Scale to investigate whether sugammadex as reversal agents of NMB&#xD;
        reduces the incidence of EA in pediatric patients who undergo strabismus surgery.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">August 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 15, 2024</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 (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The incidence of EA in postanesthesia care unit (PACU)</measure>
      <time_frame>EA is assessed three times at 15-min intervals from the end of anesthesia to dischrage from PACU.</time_frame>
      <description>EA is assessed with the PAED scale in PACU. EA is defined as the score is 10 or higher.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">76</enrollment>
    <condition>Emergence Delirium</condition>
    <condition>Strabismus</condition>
    <condition>Pediatric ALL</condition>
    <arm_group>
      <arm_group_label>group neostigmine</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>If TOF count is 1 or less, wait until it becomes 2 and then give the patient neostigmine dose of 50mcg/kg. If TOF count shows 4 with fade, 40mcg/kg of neostigmine is administered and without fade, 20mcg/kg is administered.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>group sugammadex</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>If TOF count shows 0 and PTC (posttetanic count) is 1 or more, sugamadex administered dose of 4mg/kg. If TOF count shows 1 or more, 2mg/kg is administered.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bridion 200 MG in 2 ML Injection</intervention_name>
      <description>Sugammadex and neostigmine are administered at the end of surgery after assessment of the level of neuromuscular blockade is done. The dosage of each revesal agent is determined with response to TOF or PTC.</description>
      <arm_group_label>group sugammadex</arm_group_label>
      <other_name>Bridion</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Neostigmine Methylsulfate</intervention_name>
      <description>Sugammadex and neostigmine are administered at the end of surgery after assessment of the level of neuromuscular blockade is done. The dosage of each revesal agent is determined with response to TOF or PTC.</description>
      <arm_group_label>group neostigmine</arm_group_label>
      <other_name>neostigmine</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Pateints scheduled elective stramismus surgery aged 4-7 with American Society of&#xD;
               Anesthesiologists (ASA) classification 1-3.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  ASA classification 3 or more&#xD;
  &#xD;
            -  impaired liver function&#xD;
  &#xD;
            -  impaired kidney function&#xD;
  &#xD;
            -  myasthenia gravis or other neuromuscular disorders&#xD;
  &#xD;
            -  history of drug allergy&#xD;
  &#xD;
            -  cardiovascular disease or arryrhthmia&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>4 Years</minimum_age>
      <maximum_age>7 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yea-Ji Lee, M.D Ph. D</last_name>
      <role>Principal Investigator</role>
      <affiliation>Konkuk University Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yea-Ji Lee, M.D Ph. D</last_name>
      <phone>+82-2-2030-5450</phone>
      <email>ladydaisy82@naver.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Konkuk University Medical Center</investigator_affiliation>
      <investigator_full_name>Yea-Ji Lee</investigator_full_name>
      <investigator_title>Assisstant professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <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>Neostigmine</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06035757
  org study id: KUMC2023-05-082
  nct id: NCT06035757
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The present tiral conduted to demonstrate the administration of sugammadex as reversal of
        neuromuscular blockade agent reduces the incedence of emergence agitation (EA) comparing to
        neostigmine
  EA is one of the most common postoperative complications in after general anesthesia in
        pre-school aged pediatric patients. There are several causes contributed to occurrence of EA
        such as postoperative pain, type of surgery and surgical site, hyperthermia or hypothermia.
        Some researches showed that the occurrence of EA is associated with patients' anxiety and we
        inferred that patients' anxiety after general anesthesia could be related to ability to
        breathe. Ability to breathe is highly associated with level of residual neuromuscular
        blockade (NMB) after recovery from general anesthesia. We evaluate the Pediatric Anesthesia
        Emergence Delirium (PAED) Scale to investigate whether sugammadex as reversal agents of NMB
        reduces the incidence of EA in pediatric patients who undergo strabismus surgery.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Participant, Outcomes Assessor)
  measure: The incidence of EA in postanesthesia care unit (PACU)
  time frame: EA is assessed three times at 15-min intervals from the end of anesthesia to dischrage from PACU.
  description: EA is assessed with the PAED scale in PACU. EA is defined as the score is 10 or higher.
  arm group label: group neostigmine
  arm group type: Active Comparator
  description: If TOF count is 1 or less, wait until it becomes 2 and then give the patient neostigmine dose of 50mcg/kg. If TOF count shows 4 with fade, 40mcg/kg of neostigmine is administered and without fade, 20mcg/kg is administered.
  arm group label: group sugammadex
  arm group type: Active Comparator
  description: If TOF count shows 0 and PTC (posttetanic count) is 1 or more, sugamadex administered dose of 4mg/kg. If TOF count shows 1 or more, 2mg/kg is administered.
  intervention type: Drug
  intervention name: Bridion 200 MG in 2 ML Injection
  description: Sugammadex and neostigmine are administered at the end of surgery after assessment of the level of neuromuscular blockade is done. The dosage of each revesal agent is determined with response to TOF or PTC.
  arm group label: group sugammadex
  other name: Bridion
  intervention type: Drug
  intervention name: Neostigmine Methylsulfate
  description: Sugammadex and neostigmine are administered at the end of surgery after assessment of the level of neuromuscular blockade is done. The dosage of each revesal agent is determined with response to TOF or PTC.
  arm group label: group neostigmine
  other name: neostigmine
  criteria: 
  gender: All
  minimum age: 4 Years
  maximum age: 7 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Yea-Ji Lee, M.D Ph. D
  role: Principal Investigator
  affiliation: Konkuk University Medical Center
  last name: Yea-Ji Lee, M.D Ph. D
  phone: +82-2-2030-5450
  email: ladydaisy82@naver.com
  responsible party type: Principal Investigator
  investigator affiliation: Konkuk University Medical Center
  investigator full name: Yea-Ji Lee
  investigator title: Assisstant professor
  mesh term: Strabismus
  mesh term: Emergence Delirium
  mesh term: Neostigmine