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Effect of Glycopyrrolate and Atropine on Catheter-Related Bladder Discomfort

Primary Purpose

Catheter Site Discomfort, Complications, Anesthesia

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Glycopyrrolate

Atropine

About this trial

This is an interventional prevention trial for Catheter Site Discomfort

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Seoul National University of HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Glycopyrrolate

Atropine

Arm Description

Glycopyrrolate will be administered as the adjuncts of neuromuscular blocker reversal agent.

Atropine will be administered as the adjuncts of neuromuscular blocker reversal agent.

Outcomes

Primary Outcome Measures

Catheter-related bladder discomfort

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

Secondary Outcome Measures

Catheter-related bladder discomfort

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

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.

Nausea

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

Vomiting

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

Dry mouth

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

Flushing

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

Blurred vision

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

Dizziness

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

Analgesics

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

Full Information

NCT ID

NCT02228473

First Posted

August 27, 2014

Last Updated

October 27, 2014

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02228473

Brief Title

Effect of Glycopyrrolate and Atropine on Catheter-Related Bladder Discomfort

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Unknown status

Study Start Date

September 2014 (undefined)

Primary Completion Date

February 2015 (Anticipated)

Study Completion Date

March 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Catheter Site Discomfort, Complications, Anesthesia, Urinary Bladder Neoplasms

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Glycopyrrolate

Arm Type

Experimental

Arm Description

Glycopyrrolate will be administered as the adjuncts of neuromuscular blocker reversal agent.

Arm Title

Atropine

Arm Type

Active Comparator

Arm Description

Atropine will be administered as the adjuncts of neuromuscular blocker reversal agent.

Intervention Type

Drug

Intervention Name(s)

Glycopyrrolate

Intervention Description

Glycopyrrolate will be administered.

Intervention Type

Drug

Intervention Name(s)

Atropine

Intervention Description

Atropine will be administered.

Primary Outcome Measure Information:

Title

Catheter-related bladder discomfort

Description

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

Time Frame

1 hour postoperatively

Secondary Outcome Measure Information:

Title

Catheter-related bladder discomfort

Description

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

Time Frame

0, 6 and 24 hour postoperatively

Title

Hemodynamic parameters

Description

Time Frame

0, 1, 5, 10 minute postoperatively

Title

Nausea

Description

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

Time Frame