Catheter Site DiscomfortNCT02096224
Sevoflurane Versus Desflurane for Catheter-related Bladder Discomfort
A study testing Sevoflurane and Desflurane in people with Catheter Site Discomfort and Complications, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
We want to evaluate the efficacy of the sevoflurane and desflurane for the prevention of catheter-related bladder discomfort. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Catheter Site Discomfort, Complications, Anesthesia
- What is being tested?
- Sevoflurane and Desflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2014to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for transurethral bladder excision under general anesthesia
- ASA I-III
Who cannot join
- Bladder outflow obstruction
- Overactive bladder
- End-stage renal disease
- Neurogenic bladder
- Heart failure
- Arrhythmia
Show all 11Show fewer
- Morbid obesity
- Use of chronic analgesic medication
- Hepatic disease
- Pulmonary disease
- Psychiatric disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Sevoflurane, Desflurane
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Sevoflurane will be used.
DesfluraneDrug
Desflurane will be used
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Experimental | Sevoflurane will be administered as the maintenance agent of general anesthesia. Receives: Drug: Sevoflurane |
| Desflurane | Active comparator | Desflurane will be administered as the maintenance agent of general anesthesia. Receives: Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheter-related bladder discomfort
Catheter-related bladder discomfort will be measured for 24 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe).
Measured: 24 hour postoperatively
Secondary outcomes (4)
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).
Measured: 0, 1, 6 and 24 hour postoperatively
Nausea
The degree of nausea will be assessed as none, mild, moderate and severe at 0, 1, 6 and 24 hour postoperatively.
Measured: 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.
Measured: 0, 1, 6 and 24 hour postoperatively
Dry mouth
Dry mouth after the admission of operating room will be assessed. (score:0-10)
Measured: 0 houe after admission of operating room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Catheter Site DiscomfortStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hee-Pyoung Park, PhD, Study chair, Seoul National University of Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096224
- Sponsor's protocol ID
- CRBDSevoDes
- Status last verified
- Mar 2014
- First submitted
- 21 Mar 2014
- Last updated
- 2 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26830645
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Sevoflurane and Desflurane on Prevention of Catheter-related Bladder Discomfort
- ClinicalTrials.gov ID
- NCT02096224
- Acronym / sponsor ID
- CRBDSevoDes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Experimental | Drug: SevofluraneSevoflurane will be administered as the maintenance agent of general anesthesia. |
| Desflurane | Active comparator | Drug: DesfluraneDesflurane will be administered as the maintenance agent of general anesthesia. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for transurethral bladder excision under general anesthesia
- ASA I-III
Key exclusion criteria (11 listed)
- Bladder outflow obstruction
- Overactive bladder
- End-stage renal disease
- Neurogenic bladder
- Heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SevofluraneSevoflurane will be used. | Drug | Sevoflurane |
| DesfluraneDesflurane will be used | Drug | Desflurane |
Primary outcome
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).
4 secondary outcomes
Catheter-related bladder discomfort
Time frame: 0, 1, 6 and 24 hour postoperatively
Nausea
Time frame: 0, 1, 6 and 24 hour postoperatively
Vomiting
Time frame: 0, 1, 6 and 24 hour postoperatively
Dry mouth
Time frame: 0 houe after admission of operating room
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2014.
- Derived from this study: PubMed 26830645Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hee-Pyoung Park, PhD study chair
Seoul National University of Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane and Desflurane in people with Catheter Site Discomfort and Complications, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Catheter-related bladder discomfort (time frame: 24 hour postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02096224, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2014.