Effect of Glycopyrrolate and Atropine on Catheter-Related Bladder Discomfort

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02228473
• Collaborator: (none)
• Enrollment: 76
• Location: 1
• Arms: 2
• Duration (Months): 5.9
• Patients Per Site Per Month: 12.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Catheter Site Discomfort; Complications; Anesthesia; Urinary Bladder Neoplasms	Drug: Glycopyrrolate; Drug: Atropine	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 76 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Effect of Glycopyrrolate and Atropine as Adjuncts to Reversal of Non-Depolarizing Neuromuscular Blocking Agents on Postoperative Catheter-Related Bladder Discomfort
• Study Start Date: Sep 1, 2014
• Anticipated Primary Completion Date: Feb 1, 2015
• Anticipated Study Completion Date: Mar 1, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Catheter-related bladder discomfort [1 hour postoperatively]

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

Secondary Outcome Measures

1. Catheter-related bladder discomfort [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).

2. Hemodynamic parameters [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.

3. Nausea [0, 1, 6 and 24 hour postoperatively]

   Nausea will be measured at 0, 1, 6 and 24 hour postoperatively.

4. Vomiting [0, 1, 6 and 24 hour postoperatively]

   Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively.

5. Dry mouth [0, 1, 6 and 24 hour postoperatively]

   Dry mouth will be measured at 0, 1, 6 and 24 hour postoperatively.

6. Flushing [0, 1, 6 and 24 hour postoperatively]

   Flushing will be measured at 0, 1, 6 and 24 hour postoperatively.

7. Blurred vision [0, 1, 6 and 24 hour postoperatively]

   Blurred vision will be measured at 0, 1, 6 and 24 hour postoperatively.

8. Dizziness [0, 1, 6 and 24 hour postoperatively]

   Dizziness will be measured at 0, 1, 6 and 24 hour postoperatively.

9. Analgesics [0, 1, 6 and 24 hour postoperatively]

   The amount of analgesics will be measured at 0, 1, 6 and 24 hour postoperatively.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University of Hospital	Seoul, Korea, Republic of		Korea, Republic of

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT02228473
• Other Study ID Numbers: CRBDGlycoAtr
• First Posted: Aug 29, 2014
• Last Update Posted: Oct 28, 2014
• Last Verified: Aug 1, 2014

• Additional relevant MeSH terms: Urinary Bladder Neoplasms; Atropine; Glycopyrrolate

Study Results

No Results Posted as of Oct 28, 2014