<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/NCT03294018</url>
  </required_header>
  <id_info>
    <org_study_id>IRB17-00540</org_study_id>
    <nct_id>NCT03294018</nct_id>
  </id_info>
  <brief_title>Heart Rate Changes Following the Administration of Sugammadex</brief_title>
  <official_title>Heart Rate Changes Following the Administration of Sugammadex</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Joseph D. Tobias</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nationwide Children's 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>
      This a prospective study when the clinician decides to use sugammadex, heart rate will be&#xD;
      recorded every minute for 15 minutes following its administration. If bradycardia occurs and&#xD;
      a clinical decision is made to treat it, the medications and doses used will be recorded.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 6, 2017</start_date>
  <completion_date type="Actual">January 10, 2019</completion_date>
  <primary_completion_date type="Actual">January 10, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Bradycardia during sugammadex administration</measure>
    <time_frame>intraoperative</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">276</enrollment>
  <condition>Bradycardia</condition>
  <arm_group>
    <arm_group_label>Bradycardia during sugammadex administration</arm_group_label>
    <description>Recording any heart rate changes during planned administration of sugammadex.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Recording heart rate changes</intervention_name>
    <description>Recording heart rate changes during planned sugammadex administration.</description>
    <arm_group_label>Bradycardia during sugammadex administration</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Male and female 0-18 years old undergoing surgery with anesthetic plan with sugammadex.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient age 0-18 years&#xD;
&#xD;
          -  Anesthetic plan includes NMB reversal with sugammadex&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Sugammadex not used during the case&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>September 22, 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 8, 2019</last_update_submitted>
  <last_update_submitted_qc>October 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Nationwide Children's Hospital</investigator_affiliation>
    <investigator_full_name>Joseph D. Tobias</investigator_full_name>
    <investigator_title>Chairman, Professor of Anesthesiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bradycardia</mesh_term>
  </condition_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/NCT03294018
org study id: IRB17-00540
nct id: NCT03294018
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This a prospective study when the clinician decides to use sugammadex, heart rate will be
      recorded every minute for 15 minutes following its administration. If bradycardia occurs and
      a clinical decision is made to treat it, the medications and doses used will be recorded.
observational model: Case-Only
time perspective: Prospective
measure: Bradycardia during sugammadex administration
time frame: intraoperative
arm group label: Bradycardia during sugammadex administration
description: Recording any heart rate changes during planned administration of sugammadex.
intervention type: Other
intervention name: Recording heart rate changes
description: Recording heart rate changes during planned sugammadex administration.
arm group label: Bradycardia during sugammadex administration
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Nationwide Children's Hospital
investigator full name: Joseph D. Tobias
investigator title: Chairman, Professor of Anesthesiology
mesh term: Bradycardia