<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/NCT04407078</url>
  </required_header>
  <id_info>
    <org_study_id>AJIRB-MED-OBS-18-273</org_study_id>
    <nct_id>NCT04407078</nct_id>
  </id_info>
  <brief_title>Sugammadex on Remifentanil Ce for Preventing Emergence Cough in Female</brief_title>
  <official_title>Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ajou University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ajou University School 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>
      The purpose of this study is to investigate the optimal Ce of remifentanil for preventing&#xD;
      emergence cough following extubation during general anesthesia in female who are reversed&#xD;
      with sugammadex or neostigmine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Remifentanil is a potent ultrashort-acting opioid, with rapid onset and offset of drug&#xD;
      effect. It allows rapid anesthetic emergence even after a prolonged infusion, and decreases&#xD;
      the at-risk time during extubation. In addition, cough suppression of remifentanil enables&#xD;
      smooth extubation with reduced complications. However, the infusion of remifentanil&#xD;
      suppresses the emergence cough effectively in clinical practice, whereas it still delays the&#xD;
      awakening from anesthesia, resulting in prolonged emergence time. Reduced Ce of remifentanil&#xD;
      during emergence would decrease the adverse events that are associated with remifentanil&#xD;
      infusion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2, 2019</start_date>
  <completion_date type="Actual">January 6, 2021</completion_date>
  <primary_completion_date type="Actual">January 6, 2021</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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>optimal Ce of remifentanil</measure>
    <time_frame>from the ene of surgery until endotracheal extubation</time_frame>
    <description>Using Dixon methods, evaluating of optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Gallbladder Diseases</condition>
  <arm_group>
    <arm_group_label>Sugammadex group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sugammadex group receives the intravenous sugammadex of 2 mg/kg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Neostigmine group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Neostigmine group receives the intravenous neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sugammadex Injectable Product</intervention_name>
    <description>Sugammadex of 2 mg/kg is injected.</description>
    <arm_group_label>Sugammadex group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Neostigmine Injectable Product</intervention_name>
    <description>Neostigmine of 50 ug/kg and Glycopyrrolate of 10 ug/kg are injected.</description>
    <arm_group_label>Neostigmine group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Laparoscopic cholecystectomy under general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI &gt; 30 kg/m2, respiratory infection, uncontrolled hypertension&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine</name>
      <address>
        <city>Suwon</city>
        <state>Gyeonggido</state>
        <zip>16499</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>January 6, 2021</last_update_submitted>
  <last_update_submitted_qc>January 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ajou University School of Medicine</investigator_affiliation>
    <investigator_full_name>Ji Eun Kim</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gallbladder Diseases</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>


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/NCT04407078
org study id: AJIRB-MED-OBS-18-273
nct id: NCT04407078
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate the optimal Ce of remifentanil for preventing
      emergence cough following extubation during general anesthesia in female who are reversed
      with sugammadex or neostigmine.
Remifentanil is a potent ultrashort-acting opioid, with rapid onset and offset of drug
      effect. It allows rapid anesthetic emergence even after a prolonged infusion, and decreases
      the at-risk time during extubation. In addition, cough suppression of remifentanil enables
      smooth extubation with reduced complications. However, the infusion of remifentanil
      suppresses the emergence cough effectively in clinical practice, whereas it still delays the
      awakening from anesthesia, resulting in prolonged emergence time. Reduced Ce of remifentanil
      during emergence would decrease the adverse events that are associated with remifentanil
      infusion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Care Provider)
measure: optimal Ce of remifentanil
time frame: from the ene of surgery until endotracheal extubation
description: Using Dixon methods, evaluating of optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia
arm group label: Sugammadex group
arm group type: Experimental
description: Sugammadex group receives the intravenous sugammadex of 2 mg/kg.
arm group label: Neostigmine group
arm group type: Placebo Comparator
description: Neostigmine group receives the intravenous neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg.
intervention type: Drug
intervention name: Sugammadex Injectable Product
description: Sugammadex of 2 mg/kg is injected.
arm group label: Sugammadex group
intervention type: Drug
intervention name: Neostigmine Injectable Product
description: Neostigmine of 50 ug/kg and Glycopyrrolate of 10 ug/kg are injected.
arm group label: Neostigmine group
criteria: 
gender: Female
minimum age: 19 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Ajou University School of Medicine
investigator full name: Ji Eun Kim
investigator title: Associate professor
mesh term: Gallbladder Diseases
mesh term: Neostigmine