<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/NCT03020706</url>
  </required_header>
  <id_info>
    <org_study_id>B-1610/367-002</org_study_id>
    <nct_id>NCT03020706</nct_id>
  </id_info>
  <brief_title>Effect of Magnesium Sulphate on Neostigmine</brief_title>
  <official_title>Effect of Magnesium Sulphate on Neostigmine-induced Reversal of Neuromuscular Block by Rocuronium</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gachon University Gil Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Gachon University Gil Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effect of magnesium sulphate on&#xD;
      neostigmine-induced reversal of neuromuscular block by rocuronium&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Comparison of reversa time by neostigmine in magnesium group and control group&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Actual">January 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>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>reversal time</measure>
    <time_frame>through study completion, an average of 90 minutes</time_frame>
    <description>reversal time: from neostigmine injection to TOF ratio 0.9</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">166</enrollment>
  <condition>Neuromuscular Blockade</condition>
  <arm_group>
    <arm_group_label>Magnesium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>magnesium sulfate, injectable intravenous administration (50mg/kg diluted in 100ml normal saline) during general anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Magnesium Sulfate, Injectable</intervention_name>
    <description>magnesium sulphate intravenous administration during general anesthesia</description>
    <arm_group_label>Magnesium</arm_group_label>
    <other_name>magnesium sulphate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA status 1 or 2&#xD;
&#xD;
          -  patients undergoing surgery for more than 60 min under general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  electrolyte abnormalities&#xD;
&#xD;
          -  medication on aminoglycoside, antiepileptic drug, magnesium&#xD;
&#xD;
          -  underweight or obesity (BMI &lt;18.5 or &gt;30)&#xD;
&#xD;
          -  renal insufficiency (Cr&gt;1.4 mg/dl)&#xD;
&#xD;
          -  AV block&#xD;
&#xD;
          -  neuromuscular disease (ex: Myathenia gravis)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sang-Hwan Do, MD, Ph D</last_name>
    <role>Study Chair</role>
    <affiliation>Seoul National University Bundang Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hee-Yeon Park, MD</last_name>
    <phone>+82 10 3360 0790</phone>
    <email>hypark@gilhospital.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sang-Hwan Do, MD, Ph D</last_name>
    <email>shdo@snu.ac.kr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam</city>
        <state>Kyungi-do</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hee-Yeon Park, MD</last_name>
      <phone>+82 10 3360 0790</phone>
      <email>hypark@gilhospital.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 8, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>January 11, 2017</last_update_submitted>
  <last_update_submitted_qc>January 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gachon University Gil Medical Center</investigator_affiliation>
    <investigator_full_name>Park Hee-Yeon</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>magnesium sulphate</keyword>
  <keyword>neostigmine</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Magnesium Sulfate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03020706
org study id: B-1610/367-002
nct id: NCT03020706
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate the effect of magnesium sulphate on
      neostigmine-induced reversal of neuromuscular block by rocuronium
Comparison of reversa time by neostigmine in magnesium group and control group
allocation: Randomized
intervention model: Parallel Assignment
masking: Double (Participant, Care Provider)
measure: reversal time
time frame: through study completion, an average of 90 minutes
description: reversal time: from neostigmine injection to TOF ratio 0.9
arm group label: Magnesium
arm group type: Experimental
description: magnesium sulfate, injectable intravenous administration (50mg/kg diluted in 100ml normal saline) during general anesthesia
arm group label: Control
arm group type: No Intervention
description: No intervention
intervention type: Drug
intervention name: Magnesium Sulfate, Injectable
description: magnesium sulphate intravenous administration during general anesthesia
arm group label: Magnesium
other name: magnesium sulphate
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sang-Hwan Do, MD, Ph D
role: Study Chair
affiliation: Seoul National University Bundang Hospital
last name: Hee-Yeon Park, MD
phone: +82 10 3360 0790
email: hypark@gilhospital.com
last name: Sang-Hwan Do, MD, Ph D
email: shdo@snu.ac.kr
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Gachon University Gil Medical Center
investigator full name: Park Hee-Yeon
investigator title: Associate professor
mesh term: Magnesium Sulfate
sharing ipd: Undecided