Effect of Glycopyrrolate and Atropine on Catheter-Related Bladder Discomfort

October 27, 2014 updated by: Seoul National University Hospital

Effect of Glycopyrrolate and Atropine as Adjuncts to Reversal of Non-Depolarizing Neuromuscular Blocking Agents on Postoperative Catheter-Related Bladder Discomfort

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, Korea, Republic of
        • Recruiting
        • Seoul National University of Hospital
        • Principal Investigator:
          • Hyun-Chang Kim, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glycopyrrolate
Glycopyrrolate will be administered as the adjuncts of neuromuscular blocker reversal agent.
Drug: Glycopyrrolate
Glycopyrrolate will be administered.
Active Comparator: Atropine
Atropine will be administered as the adjuncts of neuromuscular blocker reversal agent.
Drug: Atropine
Atropine will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1 hour postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
0, 6 and 24 hour postoperatively
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.
0, 1, 5, 10 minute postoperatively
Nausea
Time Frame: 0, 1, 6 and 24 hour postoperatively
Nausea will be measured at 0, 1, 6 and 24 hour postoperatively.
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.
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.
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.
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.
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.
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.
0, 1, 6 and 24 hour postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Hee-Pyoung Park, PhD, Seoul National University of Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

February 1, 2015

Study Completion (Anticipated)

March 1, 2015

Study Registration Dates

First Submitted

August 27, 2014

First Submitted That Met QC Criteria

August 27, 2014

First Posted (Estimate)

August 29, 2014

Study Record Updates

Last Update Posted (Estimate)

October 28, 2014

Last Update Submitted That Met QC Criteria

October 27, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRBDGlycoAtr

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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