<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/NCT04471376</url>
  </required_header>
  <id_info>
    <org_study_id>WJP20200708</org_study_id>
    <nct_id>NCT04471376</nct_id>
  </id_info>
  <brief_title>The Effect of Sugammadex During Transcranial Electrical Motor Evoked Potential Monitoring in Spinal Surgery</brief_title>
  <official_title>Intraoperative Reversal of Muscle Relaxants During Transcranial Electrical Motor Evoked Potential Monitoring in Patients Undergoing Spinal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Tiantan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Tiantan Hospital</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>
      Transcranial motor evoked potential (TcMEP) monitoring is conventionally performed during&#xD;
      neurosurgical procedures without or with minimal neuromuscular blockade (NMB) because of its&#xD;
      potential interference with signal interpretation. However, full blockade offers increased&#xD;
      anesthetic management options and facilitates surgery. Here, investigators want to assess the&#xD;
      effect of Sugammadex during TcMEP in adult patients. Sugammadex is designed to encapsulate&#xD;
      rocuronium and reverse rocuronium-induced neuromuscular blockade. 64 patients undergoing&#xD;
      thoracic or lumbar spinal surgery will be randomly allocated into sugammadex group or control&#xD;
      group under a ratio of 1 to 1. Patients will receive either continuous infusion of rocuronium&#xD;
      to produce blockade maintained at least two twitches in Train-of-Four (TOF), rocuronium&#xD;
      infusion will be discontinued and 2 mg/kg of sugammadex will be infused while dura opening in&#xD;
      sugammadex group. Whereas no muscle relaxant will be given after anesthetic induction in&#xD;
      control group. The primary aim of this study is to compare mean value of amplitudes of TcMEPs&#xD;
      in abductor pollicis brevis muscles of both upper extremities 5 minutes after dura opening.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 16, 2020</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</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>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The amplitude of MEP</measure>
    <time_frame>5 minutes after dura opening</time_frame>
    <description>mean value of amplitudes of TceMEPs in abductor pollicis brevis muscles of both upper extremities</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The amplitude of MEP</measure>
    <time_frame>10, 20, 30 and 60 minutes after dura opening</time_frame>
    <description>Mean value of amplitudes of TceMEPs in abductor pollicis brevis muscles of both upper extremities 10, 20, 30 and 60 minutes after dura opening.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The latencies of MEPs</measure>
    <time_frame>5, 10, 20, 30 and 60 minutes after dura opening.</time_frame>
    <description>Mean value of latencies of TceMEPs in abductor pollicis brevis muscles of both upper extremities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory parameters</measure>
    <time_frame>during the surgery</time_frame>
    <description>Peak respiratory pressures and incidence of peak insufflation pressure of more than 25cmH2O.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse effects of sugammadex</measure>
    <time_frame>during and 24 hours after the surgery</time_frame>
    <description>Anaphylaxis, arrhythmias, post-procedure pain, nausea and vomiting, fever and diarrhea, etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of body movement</measure>
    <time_frame>during the surgery</time_frame>
    <description>either nociception-induced movement (defined as &quot;coughing&quot; or reflexive limb movement temporally related to MEP stimulation) or excessive field movement (defined as grossly visible movement as determined by surgical and anesthesia teams).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence of neuromuscular blockade</measure>
    <time_frame>At the end of surgery</time_frame>
    <description>Recurrence of neuromuscular blockade at the end of surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor function assessment</measure>
    <time_frame>5 days after surgery</time_frame>
    <description>SMP-a scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total bleeding volume</measure>
    <time_frame>during the surgery</time_frame>
    <description>Total bleeding volume during the surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Sugammadex</condition>
  <arm_group>
    <arm_group_label>Sugammadex group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sugammadex</intervention_name>
    <description>Sugammadex group received a rocuronium infusion producing blockade by qualitative train-of-four ≥2 at the ulnar nerve. 2 mg/kg of Sugammadex will be infused when conducting TcMEP</description>
    <arm_group_label>Sugammadex group</arm_group_label>
    <other_name>Bridion</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-65 years&#xD;
&#xD;
          -  ASA status I-II&#xD;
&#xD;
          -  Patients undergo thoracic or lumbar spinal surgery&#xD;
&#xD;
          -  tcMEP monitoring during the surgery&#xD;
&#xD;
          -  Informed consent signed by patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI ≥35 Kg/m-2&#xD;
&#xD;
          -  history of epilepsy or use of antiepileptic drugs, neuromuscular disorder(s)&#xD;
&#xD;
          -  history or family history of malignant hyperthermia&#xD;
&#xD;
          -  allergies to sugammadex, NMBs or other medication(s) used during general anesthesia&#xD;
&#xD;
          -  anemia, hemoglobin &lt;110g/L,&#xD;
&#xD;
          -  TcMEPs stimulate or record site infection&#xD;
&#xD;
          -  preoperative neurological dysfunction in both upper extremities&#xD;
&#xD;
          -  cardiac pacemaker&#xD;
&#xD;
          -  pregnancy and breast-feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ruquan Han, M.D., Ph.D</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Anesthesiology, Beijing Tiantan Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Tiantan Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100070</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>April 5, 2021</last_update_submitted>
  <last_update_submitted_qc>April 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Tiantan Hospital</investigator_affiliation>
    <investigator_full_name>Ruquan Han</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The study protocol, statistical analysis plan and informed consent form will be shared beginning 3 months and ending 5 years following 5 years article publication.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Beginning 3 months and ending 5 years following 5 years article publication</ipd_time_frame>
    <ipd_access_criteria>Proposals should be directed to ruquan.han@ccmu.edu.cn. To gain access, data requestors will need to sign a data access agreement.</ipd_access_criteria>
  </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/NCT04471376
org study id: WJP20200708
nct id: NCT04471376
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Transcranial motor evoked potential (TcMEP) monitoring is conventionally performed during
      neurosurgical procedures without or with minimal neuromuscular blockade (NMB) because of its
      potential interference with signal interpretation. However, full blockade offers increased
      anesthetic management options and facilitates surgery. Here, investigators want to assess the
      effect of Sugammadex during TcMEP in adult patients. Sugammadex is designed to encapsulate
      rocuronium and reverse rocuronium-induced neuromuscular blockade. 64 patients undergoing
      thoracic or lumbar spinal surgery will be randomly allocated into sugammadex group or control
      group under a ratio of 1 to 1. Patients will receive either continuous infusion of rocuronium
      to produce blockade maintained at least two twitches in Train-of-Four (TOF), rocuronium
      infusion will be discontinued and 2 mg/kg of sugammadex will be infused while dura opening in
      sugammadex group. Whereas no muscle relaxant will be given after anesthetic induction in
      control group. The primary aim of this study is to compare mean value of amplitudes of TcMEPs
      in abductor pollicis brevis muscles of both upper extremities 5 minutes after dura opening.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: The amplitude of MEP
time frame: 5 minutes after dura opening
description: mean value of amplitudes of TceMEPs in abductor pollicis brevis muscles of both upper extremities
measure: The amplitude of MEP
time frame: 10, 20, 30 and 60 minutes after dura opening
description: Mean value of amplitudes of TceMEPs in abductor pollicis brevis muscles of both upper extremities 10, 20, 30 and 60 minutes after dura opening.
measure: The latencies of MEPs
time frame: 5, 10, 20, 30 and 60 minutes after dura opening.
description: Mean value of latencies of TceMEPs in abductor pollicis brevis muscles of both upper extremities
measure: Respiratory parameters
time frame: during the surgery
description: Peak respiratory pressures and incidence of peak insufflation pressure of more than 25cmH2O.
measure: Adverse effects of sugammadex
time frame: during and 24 hours after the surgery
description: Anaphylaxis, arrhythmias, post-procedure pain, nausea and vomiting, fever and diarrhea, etc.
measure: Incidence of body movement
time frame: during the surgery
description: either nociception-induced movement (defined as "coughing" or reflexive limb movement temporally related to MEP stimulation) or excessive field movement (defined as grossly visible movement as determined by surgical and anesthesia teams).
measure: Recurrence of neuromuscular blockade
time frame: At the end of surgery
description: Recurrence of neuromuscular blockade at the end of surgery.
measure: Motor function assessment
time frame: 5 days after surgery
description: SMP-a scale
measure: Total bleeding volume
time frame: during the surgery
description: Total bleeding volume during the surgery
arm group label: Sugammadex group
arm group type: Active Comparator
arm group label: control group
arm group type: No Intervention
intervention type: Drug
intervention name: Sugammadex
description: Sugammadex group received a rocuronium infusion producing blockade by qualitative train-of-four ≥2 at the ulnar nerve. 2 mg/kg of Sugammadex will be infused when conducting TcMEP
arm group label: Sugammadex group
other name: Bridion
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ruquan Han, M.D., Ph.D
role: Study Chair
affiliation: Department of Anesthesiology, Beijing Tiantan Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Tiantan Hospital
investigator full name: Ruquan Han
investigator title: Principal Investigator
sharing ipd: Yes
ipd description: The study protocol, statistical analysis plan and informed consent form will be shared beginning 3 months and ending 5 years following 5 years article publication.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Beginning 3 months and ending 5 years following 5 years article publication
ipd access criteria: Proposals should be directed to ruquan.han@ccmu.edu.cn. To gain access, data requestors will need to sign a data access agreement.