<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/NCT02228473</url>
  </required_header>
  <id_info>
    <org_study_id>CRBDGlycoAtr</org_study_id>
    <nct_id>NCT02228473</nct_id>
  </id_info>
  <brief_title>Effect of Glycopyrrolate and Atropine on Catheter-Related Bladder Discomfort</brief_title>
  <official_title>Effect of Glycopyrrolate and Atropine as Adjuncts to Reversal of Non-Depolarizing Neuromuscular Blocking Agents on Postoperative Catheter-Related Bladder Discomfort</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We want to evaluate the efficacy of the glycopyrrolate and atropine for the prevention of&#xD;
      catheter-related bladder discomfort.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The mechanism of catheter-related bladder discomfort is thought to be related to the&#xD;
      muscarinic receptor. The adjuncts to reversal agents such as glycopyrrolate and atropine are&#xD;
      known to block the muscarinic receptor in different ways.&#xD;
&#xD;
      We want to evaluate the efficacy of the glycopyrrolate and atropine for the prevention of&#xD;
      catheter-related bladder discomfort.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">March 2015</completion_date>
  <primary_completion_date type="Anticipated">February 2015</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Catheter-related bladder discomfort</measure>
    <time_frame>1 hour postoperatively</time_frame>
    <description>Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Catheter-related bladder discomfort</measure>
    <time_frame>0, 6 and 24 hour postoperatively</time_frame>
    <description>Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemodynamic parameters</measure>
    <time_frame>0, 1, 5, 10 minute postoperatively</time_frame>
    <description>Mean blood pressure and heart rate will be measured at 0, 1, 5, 10 minute postoperatively. Measurement at 10 minute means Mean blood pressure and heart rate at the admission of post-anesthetic care unit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nausea</measure>
    <time_frame>0, 1, 6 and 24 hour postoperatively</time_frame>
    <description>Nausea will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vomiting</measure>
    <time_frame>0, 1, 6 and 24 hour postoperatively</time_frame>
    <description>Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dry mouth</measure>
    <time_frame>0, 1, 6 and 24 hour postoperatively</time_frame>
    <description>Dry mouth will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Flushing</measure>
    <time_frame>0, 1, 6 and 24 hour postoperatively</time_frame>
    <description>Flushing will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blurred vision</measure>
    <time_frame>0, 1, 6 and 24 hour postoperatively</time_frame>
    <description>Blurred vision will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dizziness</measure>
    <time_frame>0, 1, 6 and 24 hour postoperatively</time_frame>
    <description>Dizziness will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analgesics</measure>
    <time_frame>0, 1, 6 and 24 hour postoperatively</time_frame>
    <description>The amount of analgesics will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">76</enrollment>
  <condition>Catheter Site Discomfort</condition>
  <condition>Complications</condition>
  <condition>Anesthesia</condition>
  <condition>Urinary Bladder Neoplasms</condition>
  <arm_group>
    <arm_group_label>Glycopyrrolate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Glycopyrrolate will be administered as the adjuncts of neuromuscular blocker reversal agent.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Atropine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Atropine will be administered as the adjuncts of neuromuscular blocker reversal agent.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glycopyrrolate</intervention_name>
    <description>Glycopyrrolate will be administered.</description>
    <arm_group_label>Glycopyrrolate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atropine</intervention_name>
    <description>Atropine will be administered.</description>
    <arm_group_label>Atropine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for transurethral bladder excision under general anesthesia&#xD;
&#xD;
          -  ASA I-III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Foley catheter less than 18 Fr.&#xD;
&#xD;
          -  Patients with obstruction of urinary tract&#xD;
&#xD;
          -  Patients with neurogenic bladder&#xD;
&#xD;
          -  Patients with severe obesity&#xD;
&#xD;
          -  Patients with neurologic disorder&#xD;
&#xD;
          -  Patients with chronic pain&#xD;
&#xD;
          -  Patients with allergic history to atropine or glycopyrrolate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hee-Pyoung Park, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University of Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hyun-Chang Kim, MD</last_name>
    <phone>82-10-2886-2876</phone>
    <email>onidori1979@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul National University of Hospital</name>
      <address>
        <city>Seoul, Korea, Republic of</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hee-Pyoung Park, PhD</last_name>
      <phone>+82-10-2971-7647</phone>
      <email>hppark@snu.ac.kr</email>
    </contact>
    <investigator>
      <last_name>Hyun-Chang Kim, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hee-Pyoung Park, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>October 27, 2014</last_update_submitted>
  <last_update_submitted_qc>October 27, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 28, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atropine</mesh_term>
    <mesh_term>Glycopyrrolate</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/NCT02228473
org study id: CRBDGlycoAtr
nct id: NCT02228473
lead sponsor: 
has dmc: Yes
We want to evaluate the efficacy of the glycopyrrolate and atropine for the prevention of
      catheter-related bladder discomfort.
The mechanism of catheter-related bladder discomfort is thought to be related to the
      muscarinic receptor. The adjuncts to reversal agents such as glycopyrrolate and atropine are
      known to block the muscarinic receptor in different ways.

      We want to evaluate the efficacy of the glycopyrrolate and atropine for the prevention of
      catheter-related bladder discomfort.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Catheter-related bladder discomfort
time frame: 1 hour postoperatively
description: Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe).
measure: Catheter-related bladder discomfort
time frame: 0, 6 and 24 hour postoperatively
description: Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe).
measure: Hemodynamic parameters
time frame: 0, 1, 5, 10 minute postoperatively
description: Mean blood pressure and heart rate will be measured at 0, 1, 5, 10 minute postoperatively. Measurement at 10 minute means Mean blood pressure and heart rate at the admission of post-anesthetic care unit.
measure: Nausea
time frame: 0, 1, 6 and 24 hour postoperatively
description: Nausea will be measured at 0, 1, 6 and 24 hour postoperatively.
measure: Vomiting
time frame: 0, 1, 6 and 24 hour postoperatively
description: Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively.
measure: Dry mouth
time frame: 0, 1, 6 and 24 hour postoperatively
description: Dry mouth will be measured at 0, 1, 6 and 24 hour postoperatively.
measure: Flushing
time frame: 0, 1, 6 and 24 hour postoperatively
description: Flushing will be measured at 0, 1, 6 and 24 hour postoperatively.
measure: Blurred vision
time frame: 0, 1, 6 and 24 hour postoperatively
description: Blurred vision will be measured at 0, 1, 6 and 24 hour postoperatively.
measure: Dizziness
time frame: 0, 1, 6 and 24 hour postoperatively
description: Dizziness will be measured at 0, 1, 6 and 24 hour postoperatively.
measure: Analgesics
time frame: 0, 1, 6 and 24 hour postoperatively
description: The amount of analgesics will be measured at 0, 1, 6 and 24 hour postoperatively.
arm group label: Glycopyrrolate
arm group type: Experimental
description: Glycopyrrolate will be administered as the adjuncts of neuromuscular blocker reversal agent.
arm group label: Atropine
arm group type: Active Comparator
description: Atropine will be administered as the adjuncts of neuromuscular blocker reversal agent.
intervention type: Drug
intervention name: Glycopyrrolate
description: Glycopyrrolate will be administered.
arm group label: Glycopyrrolate
intervention type: Drug
intervention name: Atropine
description: Atropine will be administered.
arm group label: Atropine
criteria: 
gender: All
minimum age: 19 Years
maximum age: 80 Years
healthy volunteers: No
last name: Hee-Pyoung Park, PhD
role: Principal Investigator
affiliation: Seoul National University of Hospital
last name: Hyun-Chang Kim, MD
phone: 82-10-2886-2876
email: onidori1979@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Urinary Bladder Neoplasms
mesh term: Atropine
mesh term: Glycopyrrolate