- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02096224
Sevoflurane Versus Desflurane for Catheter-related Bladder Discomfort
September 30, 2014 updated by: Seoul National University Hospital
Comparison of the Effects of Sevoflurane and Desflurane on Prevention of Catheter-related Bladder Discomfort
We want to evaluate the efficacy of the sevoflurane and desflurane for the prevention of catheter-related bladder discomfort.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
108
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Seoul National University of Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Sevoflurane
Sevoflurane will be administered as the maintenance agent of general anesthesia.
|
Sevoflurane will be used.
|
|
ACTIVE_COMPARATOR: Desflurane
Desflurane will be administered as the maintenance agent of general anesthesia.
|
Desflurane will be used
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Catheter-related bladder discomfort
Time Frame: 24 hour postoperatively
|
Catheter-related bladder discomfort will be measured for 24 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe).
|
24 hour postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Catheter-related bladder discomfort
Time Frame: 0, 1, 6 and 24 hour postoperatively
|
Catheter-related bladder discomfort will be measured at 0, 1, 6 and 24 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe).
|
0, 1, 6 and 24 hour postoperatively
|
|
Nausea
Time Frame: 0, 1, 6 and 24 hour postoperatively
|
The degree of nausea will be assessed as none, mild, moderate and severe at 0, 1, 6 and 24 hour postoperatively.
|
0, 1, 6 and 24 hour postoperatively
|
|
Vomiting
Time Frame: 0, 1, 6 and 24 hour postoperatively
|
The degree of vomiting will be assessed as none, mild, moderate and severe at 0, 1, 6 and 24 hour postoperatively.
|
0, 1, 6 and 24 hour postoperatively
|
|
Dry mouth
Time Frame: 0 houe after admission of operating room
|
Dry mouth after the admission of operating room will be assessed.
(score:0-10)
|
0 houe after admission of operating room
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Hee-Pyoung Park, PhD, Seoul National University of Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2014
Primary Completion (ACTUAL)
July 1, 2014
Study Completion (ACTUAL)
July 1, 2014
Study Registration Dates
First Submitted
March 21, 2014
First Submitted That Met QC Criteria
March 21, 2014
First Posted (ESTIMATE)
March 26, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
October 2, 2014
Last Update Submitted That Met QC Criteria
September 30, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Urinary Bladder Diseases
- Urinary Bladder Neoplasms
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Anesthetics, General
- Anesthetics
- Platelet Aggregation Inhibitors
- Anesthetics, Inhalation
- Desflurane
- Sevoflurane
Other Study ID Numbers
- CRBDSevoDes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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