Back to resultsSevoflurane Versus Desflurane 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
Sevoflurane
Desflurane
Sponsored by
About this trial
This is an interventional prevention trial for Catheter Site Discomfort
Eligibility Criteria
Inclusion Criteria:
- Patients scheduled for transurethral bladder excision under general anesthesia
- ASA I-III
Exclusion Criteria:
- Bladder outflow obstruction
- Overactive bladder
- End-stage renal disease
- Neurogenic bladder
- Heart failure
- Arrhythmia
- Morbid obesity
- Use of chronic analgesic medication
- Hepatic disease
- Pulmonary disease
- Psychiatric disease
Sites / Locations
- Seoul National University of Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sevoflurane
Desflurane
Arm Description
Sevoflurane will be administered as the maintenance agent of general anesthesia.
Desflurane will be administered as the maintenance agent of general anesthesia.
Outcomes
Primary Outcome Measures
Catheter-related bladder discomfort
Catheter-related bladder discomfort will be measured for 24 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 0, 1, 6 and 24 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe).
Nausea
The degree of nausea will be assessed as none, mild, moderate and severe at 0, 1, 6 and 24 hour postoperatively.
Vomiting
The degree of vomiting will be assessed as none, mild, moderate and severe at 0, 1, 6 and 24 hour postoperatively.
Dry mouth
Dry mouth after the admission of operating room will be assessed. (score:0-10)
Full Information
NCT ID
NCT02096224
First Posted
March 21, 2014
Last Updated
September 30, 2014
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02096224
Brief Title
Sevoflurane Versus Desflurane for Catheter-related Bladder Discomfort
Official Title
Comparison of the Effects of Sevoflurane and Desflurane on Prevention of Catheter-related Bladder Discomfort
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (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
We want to evaluate the efficacy of the sevoflurane and desflurane 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 volatile anesthetics such as sevoflurane and desflurane are known to block the muscarinic receptor in different ways.
We want to evaluate the efficacy of the sevoflurane and desflurane 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
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sevoflurane
Arm Type
Experimental
Arm Description
Sevoflurane will be administered as the maintenance agent of general anesthesia.
Arm Title
Desflurane
Arm Type
Active Comparator
Arm Description
Desflurane will be administered as the maintenance agent of general anesthesia.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
Sevoflurane will be used.
Intervention Type
Drug
Intervention Name(s)
Desflurane
Intervention Description
Desflurane will be used
Primary Outcome Measure Information:
Title
Catheter-related bladder discomfort
Description
Catheter-related bladder discomfort will be measured for 24 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe).
Time Frame
24 hour postoperatively
Secondary Outcome Measure Information:
Title
Catheter-related bladder discomfort
Description
Catheter-related bladder discomfort will be measured at 0, 1, 6 and 24 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe).
Time Frame
0, 1, 6 and 24 hour postoperatively
Title
Nausea
Description
The degree of nausea will be assessed as none, mild, moderate and severe at 0, 1, 6 and 24 hour postoperatively.
Time Frame
0, 1, 6 and 24 hour postoperatively
Title
Vomiting
Description
The degree of vomiting will be assessed as none, mild, moderate and severe at 0, 1, 6 and 24 hour postoperatively.
Time Frame
0, 1, 6 and 24 hour postoperatively
Title
Dry mouth
Description
Dry mouth after the admission of operating room will be assessed. (score:0-10)
Time Frame
0 houe after admission of operating room
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients scheduled for transurethral bladder excision under general anesthesia
ASA I-III
Exclusion Criteria:
Bladder outflow obstruction
Overactive bladder
End-stage renal disease
Neurogenic bladder
Heart failure
Arrhythmia
Morbid obesity
Use of chronic analgesic medication
Hepatic disease
Pulmonary disease
Psychiatric disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee-Pyoung Park, PhD
Organizational Affiliation
Seoul National University of Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University of Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
26830645
Citation
Kim HC, Hong WP, Lim YJ, Park HP. The effect of sevoflurane versus desflurane on postoperative catheter-related bladder discomfort in patients undergoing transurethral excision of a bladder tumour: a randomized controlled trial. Can J Anaesth. 2016 May;63(5):596-602. doi: 10.1007/s12630-016-0600-7. Epub 2016 Feb 1.
Results Reference
derived
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Sevoflurane Versus Desflurane for Catheter-related Bladder Discomfort
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