<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/NCT03292965</url>
  </required_header>
  <id_info>
    <org_study_id>B-1609-363-002</org_study_id>
    <nct_id>NCT03292965</nct_id>
  </id_info>
  <brief_title>Monitoring of Postoperative Residual Neuromuscular Blockade in Laparoscopic Surgery</brief_title>
  <official_title>Monitoring of Postoperative Residual Neuromuscular Blockade in Laparoscopic Surgery: Comparison of Neostigmine and Sugammadex</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Bundang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Bundang Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Compare the reversal effect of neostigmine and sugammadex using quantitative neuromuscular&#xD;
      monitoring&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At the end of surgery, decide the dosage of reversal referring to quantitative neuromuscular&#xD;
      monitoring value (TOF). After the administration of reversal, the anesthesiologist who are&#xD;
      going to manage the participant should not check the quantitative neuromuscular monitoring&#xD;
      and determine the timing of extubation only with his (or her) judgement. After entering&#xD;
      post-anaesthesia care unit (PACU) measure the TOF value and check the incidence of TOF ratio&#xD;
      &gt; 0.9 between the neostigmine group and sugammadex group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 28, 2017</start_date>
  <completion_date type="Actual">November 29, 2017</completion_date>
  <primary_completion_date type="Actual">November 29, 2017</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>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the incidence of postoperative residual curarization</measure>
    <time_frame>Immediately after entering PACU</time_frame>
    <description>definition of postoperative residual curarization: TOF ration is 0.9 or over 0.9</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Neuromuscular Block, Residual</condition>
  <arm_group>
    <arm_group_label>Neostigmine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>At the end of surgery, administrating neostigmine to participants according to the protocol below:&#xD;
when train-of-four (TOF) 2-3, administrating neostigmine 50mcg/kg when TOF 4 with fade, administrating neostigmine 40mcg/kg when TOF 4 without fade, administrating neostigmine 20mcg/kg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sugammadex</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>At the end of surgery, administrating sugammadex to participants according to the protocol below:&#xD;
when TOF=0 and post-tetanic count (PTC)=1 or more, administrating sugammadex 4mg/kg when TOF=1 or more, administrating sugammadex 2mg/kg when TOF 4 without fade, administrating neostigmine 20mcg/kg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Neostigmine</intervention_name>
    <description>Referring to the randomisation allocation program, participants allocated to group neostigmine, administrate neostigmine as reversal</description>
    <arm_group_label>Neostigmine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sugammadex</intervention_name>
    <description>Referring to the randomisation allocation program, participants allocated to group sugammadex, administrate sugammadex as reversal</description>
    <arm_group_label>Sugammadex</arm_group_label>
    <other_name>Bridion</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients aged over 18 years, planned to undergoing elective laparoscopic surgery under&#xD;
             general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Obesity BMI over 30 kg/m2&#xD;
&#xD;
          -  Impairment of renal or/and liver function&#xD;
&#xD;
          -  Allergy to rocuronium, sugammadex&#xD;
&#xD;
          -  (Familial) history of malignant hyperthermia&#xD;
&#xD;
          -  Taking medicines which is affecting neuromuscular function&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>AhYoung Oh, M.D Ph. D</last_name>
    <role>Study Chair</role>
    <affiliation>Department of anesthesiology and pain medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>October 5, 2018</last_update_submitted>
  <last_update_submitted_qc>October 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Bundang Hospital</investigator_affiliation>
    <investigator_full_name>LEE YEA JI</investigator_full_name>
    <investigator_title>clinical professor of department of anesthesiology and pain medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delayed Emergence from Anesthesia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neostigmine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>May 11, 2022</submitted>
    <returned>February 9, 2023</returned>
  </pending_results>
  <!-- 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/NCT03292965
org study id: B-1609-363-002
nct id: NCT03292965
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Compare the reversal effect of neostigmine and sugammadex using quantitative neuromuscular
      monitoring
At the end of surgery, decide the dosage of reversal referring to quantitative neuromuscular
      monitoring value (TOF). After the administration of reversal, the anesthesiologist who are
      going to manage the participant should not check the quantitative neuromuscular monitoring
      and determine the timing of extubation only with his (or her) judgement. After entering
      post-anaesthesia care unit (PACU) measure the TOF value and check the incidence of TOF ratio
      > 0.9 between the neostigmine group and sugammadex group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: the incidence of postoperative residual curarization
time frame: Immediately after entering PACU
description: definition of postoperative residual curarization: TOF ration is 0.9 or over 0.9
arm group label: Neostigmine
arm group type: Active Comparator
description: At the end of surgery, administrating neostigmine to participants according to the protocol below:
when train-of-four (TOF) 2-3, administrating neostigmine 50mcg/kg when TOF 4 with fade, administrating neostigmine 40mcg/kg when TOF 4 without fade, administrating neostigmine 20mcg/kg
arm group label: Sugammadex
arm group type: Active Comparator
description: At the end of surgery, administrating sugammadex to participants according to the protocol below:
when TOF=0 and post-tetanic count (PTC)=1 or more, administrating sugammadex 4mg/kg when TOF=1 or more, administrating sugammadex 2mg/kg when TOF 4 without fade, administrating neostigmine 20mcg/kg
intervention type: Drug
intervention name: Neostigmine
description: Referring to the randomisation allocation program, participants allocated to group neostigmine, administrate neostigmine as reversal
arm group label: Neostigmine
intervention type: Drug
intervention name: Sugammadex
description: Referring to the randomisation allocation program, participants allocated to group sugammadex, administrate sugammadex as reversal
arm group label: Sugammadex
other name: Bridion
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: AhYoung Oh, M.D Ph. D
role: Study Chair
affiliation: Department of anesthesiology and pain medicine
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Bundang Hospital
investigator full name: LEE YEA JI
investigator title: clinical professor of department of anesthesiology and pain medicine
mesh term: Delayed Emergence from Anesthesia
mesh term: Neostigmine
sharing ipd: Undecided
submitted: May 11, 2022
returned: February 9, 2023