<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/NCT01690364</url>
  </required_header>
  <id_info>
    <org_study_id>2012-05-090-001</org_study_id>
    <nct_id>NCT01690364</nct_id>
  </id_info>
  <brief_title>Comparison of the Effects of Vecuronium and Cisatracurium on Electrophysiologic Monitoring During Neurosurgery</brief_title>
  <official_title>Comparison of the Effects of Vecuronium and Cisatracurium on Electrophysiologic Monitoring During Neurosurgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recently intraoperative motor evoked potential monitoring (MEP) is widely used to reduce&#xD;
      neural damage during neurosurgery.&#xD;
&#xD;
      As neuromuscular blockade(NMB) during MEP monitoring decreases the amplitude of MEP, partial&#xD;
      NMB is usually maintained during general anesthesia. Continuous infusion of NMB agent is&#xD;
      preferred than bolus infusion during MEP monitoring. There are a lot of NMB agents in&#xD;
      clinical use. But there have been no reports about the effect of changing NMB agent on&#xD;
      efficacy of MEP monitoring.&#xD;
&#xD;
      Therefore, the investigators performed a randomized controlled trial to evaluate the effect&#xD;
      of changing NMB agent on the variability of MEP amplitude during neurosurgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recently intraoperative motor evoked potential monitoring (MEP) is widely used to reduce&#xD;
      neural damage during neurosurgery.&#xD;
&#xD;
      As neuromuscular blockade(NMB) during MEP monitoring decreases the amplitude of MEP, partial&#xD;
      NMB is usually maintained during general anesthesia. Continuous infusion of NMB agent is&#xD;
      preferred than bolus infusion during MEP monitoring. There are a lot of NMB agents in&#xD;
      clinical use. But there have been no reports about the effect of changing NMB agent on&#xD;
      efficacy of MEP monitoring.&#xD;
&#xD;
      Therefore, the investigators performed a randomized controlled trial to evaluate the effect&#xD;
      of changing NMB agent on the variability of MEP amplitude during neurosurgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</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, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MEP amplitude</measure>
    <time_frame>15 min after anesthetic induction</time_frame>
    <description>intraoperative motor evoked potential monitoring amplitude</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MEP amplitude</measure>
    <time_frame>30 min after anesthetic induction</time_frame>
    <description>intraoperative motor evoked potential monitoring amplitude</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MEP amplitude</measure>
    <time_frame>45 min after anesthetic induction</time_frame>
    <description>intraoperative motor evoked potential monitoring amplitude</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MEP amplitude</measure>
    <time_frame>60 min after anesthetic induction</time_frame>
    <description>intraoperative motor evoked potential monitoring amplitude</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MEP amplitude</measure>
    <time_frame>75 min after anesthetic induction</time_frame>
    <description>intraoperative motor evoked potential monitoring amplitude</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MEP amplitude</measure>
    <time_frame>90 min after anesthetic induction</time_frame>
    <description>intraoperative motor evoked potential monitoring amplitude</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MEP amplitude</measure>
    <time_frame>105 min after anesthetic induction</time_frame>
    <description>intraoperative motor evoked potential monitoring amplitude</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MEP amplitude</measure>
    <time_frame>120 min after anesthetic induction</time_frame>
    <description>intraoperative motor evoked potential monitoring amplitude</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MEP amplitude</measure>
    <time_frame>135 min after anesthetic induction</time_frame>
    <description>intraoperative motor evoked potential monitoring amplitude</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MEP amplitude</measure>
    <time_frame>150 min after anesthetic induction</time_frame>
    <description>intraoperative motor evoked potential monitoring amplitude</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MEP amplitude</measure>
    <time_frame>165 min after anesthetic induction</time_frame>
    <description>intraoperative motor evoked potential monitoring amplitude</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MEP amplitude</measure>
    <time_frame>180 min after anesthetic induction</time_frame>
    <description>intraoperative motor evoked potential monitoring amplitude</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MEP amplitude</measure>
    <time_frame>195 min after anesthetic induction</time_frame>
    <description>intraoperative motor evoked potential monitoring amplitude</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MEP amplitude</measure>
    <time_frame>210 min after anesthetic induction</time_frame>
    <description>intraoperative motor evoked potential monitoring amplitude</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MEP amplitude</measure>
    <time_frame>225 min after anesthetic induction</time_frame>
    <description>intraoperative motor evoked potential monitoring amplitude</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MEP amplitude</measure>
    <time_frame>240 min after anesthetic induction</time_frame>
    <description>intraoperative motor evoked potential monitoring amplitude</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MEP amplitude</measure>
    <time_frame>255 min after anesthetic induction</time_frame>
    <description>intraoperative motor evoked potential monitoring amplitude</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MEP amplitude</measure>
    <time_frame>270 min after anesthetic induction</time_frame>
    <description>intraoperative motor evoked potential monitoring amplitude</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MEP amplitude</measure>
    <time_frame>285 min after anesthetic induction</time_frame>
    <description>intraoperative motor evoked potential monitoring amplitude</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MEP amplitude</measure>
    <time_frame>300 min after anesthetic induction</time_frame>
    <description>intraoperative motor evoked potential monitoring amplitude</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Coefficient of variation (CV) of MEP amplitude</measure>
    <time_frame>at the end of the surgery (5H after the start of surgery)</time_frame>
    <description>Coefficient of variation (CV) of intraoperative motor evoked potential monitoring amplitude</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average of MEP amplitudes</measure>
    <time_frame>at the end of the surgery (5H after the start of surgery)</time_frame>
    <description>Average of all measured MEP amplitudes in a subject</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The frequency of adjusting the infusion dose of muscle relaxant</measure>
    <time_frame>at the end of the surgery (5H after the start of surgery)</time_frame>
    <description>The frequency of adjusting the infusion dose of muscle relaxant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average of Latency of MEP amplitude</measure>
    <time_frame>at the end of the surgery (5H after the start of surgery)</time_frame>
    <description>Average of Latency of MEP amplitude</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Motor Evoked Potential Monitoring</condition>
  <condition>General Anesthesia</condition>
  <condition>Neurosurgery</condition>
  <condition>Brain Tumor</condition>
  <condition>Spine Tumor</condition>
  <condition>Cerebral Aneurysm</condition>
  <arm_group>
    <arm_group_label>Cisatracurium Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MEP monitoring with continuous infusion of cisatracurium during general anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vecuronium Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>MEP monitoring with continuous infusion of vecuronium during general anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MEP monitoring with continuous infusion of vecuronium during general anesthesia</intervention_name>
    <description>MEP monitoring with continuous infusion of vecuronium during general anesthesia</description>
    <arm_group_label>Vecuronium Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MEP monitoring with continuous infusion of cisatracurium during general anesthesia</intervention_name>
    <description>MEP monitoring with continuous infusion of cisatracurium during general anesthesia</description>
    <arm_group_label>Cisatracurium Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients undergoing neurosurgery with intraoperative motor evoked potential&#xD;
             monitoring&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who can not undergo motor evoked potential monitoring due to central or&#xD;
             peripheral neuromuscular disease (e.g. Cerebral palsy, Myasthenia gravis, Acute spinal&#xD;
             injury, neurologic shock)&#xD;
&#xD;
          -  Patients with hepatic or renal disease with altered metabolism of vecuronium&#xD;
&#xD;
          -  Patients with medication which influence the metabolism of vecuronium (e.g. calcium&#xD;
             channel blocker, aminoglycoside antibiotics, Lithium, MgSO4)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>December 2013</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>December 24, 2013</last_update_submitted>
  <last_update_submitted_qc>December 24, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 25, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>Jeong Jin Lee</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Motor evoked potential monitoring</keyword>
  <keyword>General Anesthesia</keyword>
  <keyword>Neurosurgery</keyword>
  <keyword>Cisatracurium</keyword>
  <keyword>Vecuronium</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intracranial Aneurysm</mesh_term>
    <mesh_term>Aneurysm</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
    <mesh_term>Cisatracurium</mesh_term>
    <mesh_term>Vecuronium Bromide</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/NCT01690364
org study id: 2012-05-090-001
nct id: NCT01690364
lead sponsor: 
has dmc: No
Recently intraoperative motor evoked potential monitoring (MEP) is widely used to reduce
      neural damage during neurosurgery.

      As neuromuscular blockade(NMB) during MEP monitoring decreases the amplitude of MEP, partial
      NMB is usually maintained during general anesthesia. Continuous infusion of NMB agent is
      preferred than bolus infusion during MEP monitoring. There are a lot of NMB agents in
      clinical use. But there have been no reports about the effect of changing NMB agent on
      efficacy of MEP monitoring.

      Therefore, the investigators performed a randomized controlled trial to evaluate the effect
      of changing NMB agent on the variability of MEP amplitude during neurosurgery.
Recently intraoperative motor evoked potential monitoring (MEP) is widely used to reduce
      neural damage during neurosurgery.

      As neuromuscular blockade(NMB) during MEP monitoring decreases the amplitude of MEP, partial
      NMB is usually maintained during general anesthesia. Continuous infusion of NMB agent is
      preferred than bolus infusion during MEP monitoring. There are a lot of NMB agents in
      clinical use. But there have been no reports about the effect of changing NMB agent on
      efficacy of MEP monitoring.

      Therefore, the investigators performed a randomized controlled trial to evaluate the effect
      of changing NMB agent on the variability of MEP amplitude during neurosurgery.
allocation: Randomized
intervention model: Parallel Assignment
masking: Double (Participant, Outcomes Assessor)
measure: MEP amplitude
time frame: 15 min after anesthetic induction
description: intraoperative motor evoked potential monitoring amplitude
measure: MEP amplitude
time frame: 30 min after anesthetic induction
description: intraoperative motor evoked potential monitoring amplitude
measure: MEP amplitude
time frame: 45 min after anesthetic induction
description: intraoperative motor evoked potential monitoring amplitude
measure: MEP amplitude
time frame: 60 min after anesthetic induction
description: intraoperative motor evoked potential monitoring amplitude
measure: MEP amplitude
time frame: 75 min after anesthetic induction
description: intraoperative motor evoked potential monitoring amplitude
measure: MEP amplitude
time frame: 90 min after anesthetic induction
description: intraoperative motor evoked potential monitoring amplitude
measure: MEP amplitude
time frame: 105 min after anesthetic induction
description: intraoperative motor evoked potential monitoring amplitude
measure: MEP amplitude
time frame: 120 min after anesthetic induction
description: intraoperative motor evoked potential monitoring amplitude
measure: MEP amplitude
time frame: 135 min after anesthetic induction
description: intraoperative motor evoked potential monitoring amplitude
measure: MEP amplitude
time frame: 150 min after anesthetic induction
description: intraoperative motor evoked potential monitoring amplitude
measure: MEP amplitude
time frame: 165 min after anesthetic induction
description: intraoperative motor evoked potential monitoring amplitude
measure: MEP amplitude
time frame: 180 min after anesthetic induction
description: intraoperative motor evoked potential monitoring amplitude
measure: MEP amplitude
time frame: 195 min after anesthetic induction
description: intraoperative motor evoked potential monitoring amplitude
measure: MEP amplitude
time frame: 210 min after anesthetic induction
description: intraoperative motor evoked potential monitoring amplitude
measure: MEP amplitude
time frame: 225 min after anesthetic induction
description: intraoperative motor evoked potential monitoring amplitude
measure: MEP amplitude
time frame: 240 min after anesthetic induction
description: intraoperative motor evoked potential monitoring amplitude
measure: MEP amplitude
time frame: 255 min after anesthetic induction
description: intraoperative motor evoked potential monitoring amplitude
measure: MEP amplitude
time frame: 270 min after anesthetic induction
description: intraoperative motor evoked potential monitoring amplitude
measure: MEP amplitude
time frame: 285 min after anesthetic induction
description: intraoperative motor evoked potential monitoring amplitude
measure: MEP amplitude
time frame: 300 min after anesthetic induction
description: intraoperative motor evoked potential monitoring amplitude
measure: Coefficient of variation (CV) of MEP amplitude
time frame: at the end of the surgery (5H after the start of surgery)
description: Coefficient of variation (CV) of intraoperative motor evoked potential monitoring amplitude
measure: Average of MEP amplitudes
time frame: at the end of the surgery (5H after the start of surgery)
description: Average of all measured MEP amplitudes in a subject
measure: The frequency of adjusting the infusion dose of muscle relaxant
time frame: at the end of the surgery (5H after the start of surgery)
description: The frequency of adjusting the infusion dose of muscle relaxant
measure: Average of Latency of MEP amplitude
time frame: at the end of the surgery (5H after the start of surgery)
description: Average of Latency of MEP amplitude
arm group label: Cisatracurium Group
arm group type: Experimental
description: MEP monitoring with continuous infusion of cisatracurium during general anesthesia
arm group label: Vecuronium Group
arm group type: Active Comparator
description: MEP monitoring with continuous infusion of vecuronium during general anesthesia
intervention type: Other
intervention name: MEP monitoring with continuous infusion of vecuronium during general anesthesia
description: MEP monitoring with continuous infusion of vecuronium during general anesthesia
arm group label: Vecuronium Group
intervention type: Other
intervention name: MEP monitoring with continuous infusion of cisatracurium during general anesthesia
description: MEP monitoring with continuous infusion of cisatracurium during general anesthesia
arm group label: Cisatracurium Group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Samsung Medical Center
investigator full name: Jeong Jin Lee
investigator title: Professor
mesh term: Intracranial Aneurysm
mesh term: Aneurysm
mesh term: Anesthetics
mesh term: Cisatracurium
mesh term: Vecuronium Bromide