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Propofol and Sevoflurane for Catheter-Related Bladder Discomfort

Primary Purpose

Catheter Site Discomfort, Complications, Anesthesia

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Propofol

Sevoflurane

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 propofol or sevoflurane

Sites / Locations

Seolu National University of Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Propofol

Sevoflurane

Arm Description

Propofol will be administered as the anesthetic maintenance agent.

Sevoflurane will be administered as the anesthetic maintenance 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). Patients with score >0 will be counted.

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). Patients with score >0 will be counted.

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

NCT02252445

First Posted

September 26, 2014

Last Updated

July 20, 2016

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02252445

Brief Title

Propofol and Sevoflurane for Catheter-Related Bladder Discomfort

Official Title

Effect of Propofol and Sevoflurane on Postoperative Catheter-Related Bladder Discomfort

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Completed

Study Start Date

November 2014 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

January 2015 (Actual)

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

The investigators want to evaluate the efficacy of the propofol and sevoflurane 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. Propofol and desflurane are most widely used as an anesthetic agent. Propofol and desflurane are known to block the muscarinic receptor in different ways. The investigators want to evaluate the efficacy of the propofol and sevoflurane 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

82 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Propofol

Arm Type

Active Comparator

Arm Description

Propofol will be administered as the anesthetic maintenance agent.

Arm Title

Sevoflurane

Arm Type

Experimental

Arm Description

Sevoflurane will be administered as the anesthetic maintenance agent.

Intervention Type

Drug

Intervention Name(s)

Propofol

Intervention Description

Propofol will be administered.

Intervention Type

Drug

Intervention Name(s)

Sevoflurane

Intervention Description

Sevoflurane 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). Patients with score >0 will be counted.

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). Patients with score >0 will be counted.

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