Effect of Glycopyrrolate and Atropine on Catheter-Related Bladder Discomfort

Not Applicable

• Conditions: Catheter Site Discomfort; Complications; Anesthesia; Urinary Bladder Neoplasms
• Interventions: Drug: Glycopyrrolate; Drug: Atropine

• Registration Number: NCT02228473
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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 Timeline

• Status Verified: 2014-08
• Study First Submitted: 2014-08-27
• Study First Submitted QC: 2014-08-27
• Study First Posted: 2014-08-29
• Study Start: 2014-09
• Last Update Submitted: 2014-10-27
• Last Update Posted: 2014-10-28
• Primary Completion: 2015-02
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glycopyrrolate	Glycopyrrolate	Glycopyrrolate will be administered as the adjuncts of neuromuscular blocker reversal agent.
Atropine	Atropine	Atropine will be administered as the adjuncts of neuromuscular blocker reversal agent.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
Nausea	0, 1, 6 and 24 hour postoperatively	Nausea will be measured at 0, 1, 6 and 24 hour postoperatively.
Vomiting	0, 1, 6 and 24 hour postoperatively	Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively.
Flushing	0, 1, 6 and 24 hour postoperatively	Flushing will be measured at 0, 1, 6 and 24 hour postoperatively.
Blurred vision	0, 1, 6 and 24 hour postoperatively	Blurred vision will be measured at 0, 1, 6 and 24 hour postoperatively.
Dizziness	0, 1, 6 and 24 hour postoperatively	Dizziness will be measured at 0, 1, 6 and 24 hour postoperatively.
Analgesics	0, 1, 6 and 24 hour postoperatively	The amount of analgesics will be measured at 0, 1, 6 and 24 hour postoperatively.
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).
Dry mouth	0, 1, 6 and 24 hour postoperatively	Dry mouth will be measured at 0, 1, 6 and 24 hour postoperatively.

Trial Locations

Locations (1)

Seoul National University of Hospital; 🇰🇷 Seoul, Korea, Republic of, Korea, Republic of