Effect of Glycopyrrolate and Atropine on Catheter-Related Bladder Discomfort

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02228473
• Other study ID #: CRBDGlycoAtr
• Status: Recruiting
• Phase: N/A
• First received: August 27, 2014
• Last updated: October 27, 2014
• Start date: September 2014
• Est. completion date: March 2015

Study information

• Verified date: August 2014
• Source: Seoul National University Hospital
• Contact: Hyun-Chang Kim, MD
• Phone: 82-10-2886-2876
• Email: onidori1979[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: March 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anesthesia
• Catheter Site Discomfort
• Complications
• Urinary Bladder Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University of Hospital	Seoul, Korea, Republic of

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Catheter-related bladder discomfort	Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe).	1 hour postoperatively	No
Secondary	Catheter-related bladder discomfort	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	No
Secondary	Hemodynamic parameters	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	No
Secondary	Nausea	Nausea will be measured at 0, 1, 6 and 24 hour postoperatively.	0, 1, 6 and 24 hour postoperatively	No
Secondary	Vomiting	Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively.	0, 1, 6 and 24 hour postoperatively	No
Secondary	Dry mouth	Dry mouth will be measured at 0, 1, 6 and 24 hour postoperatively.	0, 1, 6 and 24 hour postoperatively	No
Secondary	Flushing	Flushing will be measured at 0, 1, 6 and 24 hour postoperatively.	0, 1, 6 and 24 hour postoperatively	No
Secondary	Blurred vision	Blurred vision will be measured at 0, 1, 6 and 24 hour postoperatively.	0, 1, 6 and 24 hour postoperatively	No
Secondary	Dizziness	Dizziness will be measured at 0, 1, 6 and 24 hour postoperatively.	0, 1, 6 and 24 hour postoperatively	No
Secondary	Analgesics	The amount of analgesics will be measured at 0, 1, 6 and 24 hour postoperatively.	0, 1, 6 and 24 hour postoperatively	No