Catheter Site DiscomfortNCT02252445
Propofol and Sevoflurane for Catheter-Related Bladder Discomfort
A study testing Propofol and Sevoflurane in people with Catheter Site Discomfort and Complications, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigators want to evaluate the efficacy of the propofol and sevoflurane for the prevention of catheter-related bladder discomfort. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Catheter Site Discomfort, Complications, Anesthesia
- What is being tested?
- Propofol and Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2014to Jan 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Propofol and Sevoflurane on Postoperative Catheter-Related Bladder Discomfort
The investigators want to evaluate the efficacy of the propofol and sevoflurane 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. 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.
- Being tested
- Propofol, Sevoflurane
- 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.
PropofolDrug
Propofol will be administered.
SevofluraneDrug
Sevoflurane will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Active comparator | Propofol will be administered as the anesthetic maintenance agent. Receives: Drug: Propofol |
| Sevoflurane | Experimental | Sevoflurane will be administered as the anesthetic maintenance agent. Receives: Drug: Sevoflurane |
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 at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe). Patients with score >0 will be counted.
Measured: 1 hour postoperatively
Secondary outcomes (9)
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.
Measured: 0, 6 and 24 hour postoperatively
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.
Measured: 0, 1, 5, 10 minute postoperatively
Nausea
Nausea will be measured at 0, 1, 6 and 24 hour postoperatively.
Measured: 0, 1, 6 and 24 hour postoperatively
Vomiting
Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively.
Measured: 0, 1, 6 and 24 hour postoperatively
Dry Mouth
Dry mouth will be measured at 0, 1, 6 and 24 hour postoperatively.
Measured: 0, 1, 6 and 24 hour postoperatively
Flushing
Flushing will be measured at 0, 1, 6 and 24 hour postoperatively.
Measured: 0, 1, 6 and 24 hour postoperatively
Blurred Vision
Blurred vision will be measured at 0, 1, 6 and 24 hour postoperatively.
Measured: 0, 1, 6 and 24 hour postoperatively
Dizziness
Dizziness will be measured at 0, 1, 6 and 24 hour postoperatively.
Measured: 0, 1, 6 and 24 hour postoperatively
Analgesics
The amount of analgesics will be measured at 0, 1, 6 and 24 hour postoperatively.
Measured: 0, 1, 6 and 24 hour postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study startNov 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252445
- Sponsor's protocol ID
- CRBDPPFSEVO
- Status last verified
- Sep 2014
- First submitted
- 26 Sep 2014
- Last updated
- 1 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Propofol and Sevoflurane on Postoperative Catheter-Related Bladder Discomfort
- ClinicalTrials.gov ID
- NCT02252445
- Acronym / sponsor ID
- CRBDPPFSEVO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 30 Sep 2014 (estimated)
- Results
- Posted 1 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 |
|---|---|---|
| Propofol | Active comparator | Drug: PropofolPropofol will be administered as the anesthetic maintenance agent. |
| Sevoflurane | Experimental | Drug: SevofluraneSevoflurane will be administered as the anesthetic maintenance agent. |
Who may qualify
- Ages
- 19 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 (7 listed)
- Foley catheter less than 18 Fr.
- Patients with obstruction of urinary tract
- Patients with neurogenic bladder
- Patients with severe obesity
- Patients with neurologic disorder
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 |
|---|---|---|
| PropofolPropofol will be administered. | Drug | Propofol |
| SevofluraneSevoflurane will be administered. | Drug | Sevoflurane |
Primary outcome
Catheter-related Bladder Discomfort
Time frame: 1 hour postoperatively
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.
9 secondary outcomes
Catheter-related Bladder Discomfort
Time frame: 0, 6 and 24 hour postoperatively
Hemodynamic Parameters
Time frame: 0, 1, 5, 10 minute 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, 1, 6 and 24 hour postoperatively
Flushing
Time frame: 0, 1, 6 and 24 hour postoperatively
Blurred Vision
Time frame: 0, 1, 6 and 24 hour postoperatively
Dizziness
Time frame: 0, 1, 6 and 24 hour postoperatively
Analgesics
Time frame: 0, 1, 6 and 24 hour postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol and Sevoflurane 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 7 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 1 Sep 2016. 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?
Yes. Results are posted in the registry (first posted 1 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: 1 hour postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2016.