Effect of Glycopyrrolate and Atropine on Catheter-Related Bladder Discomfort

Overview

We want to evaluate the efficacy of the glycopyrrolate and atropine for the prevention of catheter-related bladder discomfort.

Full Title of Study: “Effect of Glycopyrrolate and Atropine as Adjuncts to Reversal of Non-Depolarizing Neuromuscular Blocking Agents on Postoperative Catheter-Related Bladder Discomfort”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2015

Detailed Description

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.

Interventions

  • Drug: Glycopyrrolate
    • Glycopyrrolate will be administered.
  • Drug: Atropine
    • Atropine will be administered.

Arms, Groups and Cohorts

  • Experimental: Glycopyrrolate
    • Glycopyrrolate will be administered as the adjuncts of neuromuscular blocker reversal agent.
  • Active Comparator: Atropine
    • Atropine will be administered as the adjuncts of neuromuscular blocker reversal agent.

Clinical Trial Outcome Measures

Primary Measures

  • Catheter-related bladder discomfort
    • Time Frame: 1 hour postoperatively
    • Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe).

Secondary Measures

  • Catheter-related bladder discomfort
    • Time Frame: 0, 6 and 24 hour postoperatively
    • Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe).
  • Hemodynamic parameters
    • Time Frame: 0, 1, 5, 10 minute postoperatively
    • 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.
  • Nausea
    • Time Frame: 0, 1, 6 and 24 hour postoperatively
    • Nausea will be measured at 0, 1, 6 and 24 hour postoperatively.
  • Vomiting
    • Time Frame: 0, 1, 6 and 24 hour postoperatively
    • Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively.
  • Dry mouth
    • Time Frame: 0, 1, 6 and 24 hour postoperatively
    • Dry mouth will be measured at 0, 1, 6 and 24 hour postoperatively.
  • Flushing
    • Time Frame: 0, 1, 6 and 24 hour postoperatively
    • Flushing will be measured at 0, 1, 6 and 24 hour postoperatively.
  • Blurred vision
    • Time Frame: 0, 1, 6 and 24 hour postoperatively
    • Blurred vision will be measured at 0, 1, 6 and 24 hour postoperatively.
  • Dizziness
    • Time Frame: 0, 1, 6 and 24 hour postoperatively
    • Dizziness will be measured at 0, 1, 6 and 24 hour postoperatively.
  • Analgesics
    • Time Frame: 0, 1, 6 and 24 hour postoperatively
    • The amount of analgesics will be measured at 0, 1, 6 and 24 hour postoperatively.

Participating in This Clinical Trial

Inclusion Criteria

  • Patients scheduled for transurethral bladder excision under general anesthesia – ASA I-III Exclusion Criteria:

  • Foley catheter less than 18 Fr. – Patients with obstruction of urinary tract – Patients with neurogenic bladder – Patients with severe obesity – Patients with neurologic disorder – Patients with chronic pain – Patients with allergic history to atropine or glycopyrrolate

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Hee-Pyoung Park, PhD, Principal Investigator, Seoul National University of Hospital
  • Overall Contact(s)
    • Hyun-Chang Kim, MD, 82-10-2886-2876, onidori1979@gmail.com

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