PainPhase 4CRBDEXNCT01991223
Dexmedetomidine for Catheter-related Bladder Discomfort
A Phase 4 study testing Dex infusion and NS infusion in people with Pain and Blood Pressure, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To evaluate the efficacy of dexmedetomidine 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
- Pain, Blood Pressure, Nausea
- What is being tested?
- Dex infusion and NS infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2013to Nov 2014
- Phase
- Phase 4
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for transurethral bladder resection
- ASA I-III
Who cannot join
- Patient who disagrees to participate this investigation
- Patient with severe cardiovascular disease
- Patient with small-sized foley catheter (less than 18 Fr.)
- Patinets with any urinary tract obstructions
- Patient with hyperactive or neurogenic bladder
- Patients with chronic renal failure
Show all 9Show fewer
- Patient with morbidly obese
- Patients with neurogenic disorder
- Patient with medications for chronic pain
Trial locations and contacts
1 site in 1 country.
Hyun-Chang Kim, MD contact
Hee-Pyong Park, Ph.D contact
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Hee-Pyung Park, MD PhD, 82-2-2072-2365, hppark@snu.ac.kr
Hee-Pyung Park, MD PhD
About this study
Official title: Efficacy of Dexmedetomidine for the Therapy of Catheter-related Bladder Discomfort
To evaluate the efficacy of dexmedetomidine for the prevention of catheter-related bladder discomfort
Read the detailed description
After transurethral bladder resection, large-sized foley catheter have been used for drainage of urine and residual blood. Because of urinary catheterization, patients usually experiences catheter-related bladder discomfort defined as a burning sensation with an urge to void or discomfort in the supra-pubic region caused by catheter- related bladder irritation.
Dexmedetomidine is an alpha-2 antagonist and used as an analgesic agent. The investigators try to evaluate The efficacy of dexmedetomidine for the treatment of catheter-related bladder discomfort
- Conditions
- Pain, Blood Pressure, Nausea, Vomiting, Arrhythmia
- Being tested
- Dex infusion, NS infusion
- Medical subject headings
- Pain, Nausea, Vomiting, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dex infusionDrug
Dexmedetomidine will be injected (1 mcg/kg for 10 minutes and afterward 0.3 mcg/kg/hr)
NS infusionDrug
Normal saline will be infused during surgery
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | NS infusion will be done during surgery. Receives: Drug: NS infusion |
| Dex group | Experimental | DEX infusion will be done during surgery. Receives: Drug: Dex infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with catheter-related bladder discomfort
catheter-related bladder discomfort at postoperative 1 hour was evaluated as none, mild, moderate, severe. The number of patients with mild, moderate, severe discomfort will be calculated and compared between groups.
Measured: at postoperative 1 hour
Secondary outcomes (2)
Catheter-related bladder discomfort
Catheter-related bladder discomfort will be evaluated as none, mild, moderate, severe at postoperative 0, 1, 6, 24 hours.
Measured: at postoperative 0, 1, 6, 24 hours
Pain at suprapubic area
Pain at suprapubic area will be evaluated using NRS (0:none, 100:worst imaginable) at postoperative 0, 1, 6, 24 hours
Measured: at postoperative 0, 1, 6, 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2014 (estimated)
- Study completionNov 2014 (estimated)
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 PainStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Pyoung Park, Seoul National University Hospital
- Investigators
- Hee-Pyoung Park, Principal investigator, Seoul National University of Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991223
- Sponsor's protocol ID
- CRBD_DEX_PHPKHC
- Other IDs
- CRBD_SNUH1
- Acronym
- CRBDEX
- Status last verified
- Mar 2014
- First submitted
- 18 Nov 2013
- Last updated
- 19 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim HC, Lee YH, Jeon YT, Hwang JW, Lim YJ, Park JE, Park HP. The effect of intraoperative dexmedetomidine on postoperative catheter-related bladder discomfort in patients undergoing transurethral bladder tumour resection: A double-blind randomised study. Eur J Anaesthesiol. 2015 Sep;32(9):596-601. doi: 10.1097/EJA.0000000000000196.
PubMed 25485879
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dexmedetomidine for the Therapy of Catheter-related Bladder Discomfort
- ClinicalTrials.gov ID
- NCT01991223
- Acronym / sponsor ID
- CRBDEX / CRBD_DEX_PHPKHC
- Conditions
- Pain, Blood Pressure, Nausea, Vomiting, Arrhythmia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 25 Nov 2013 (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.
To evaluate the efficacy of dexmedetomidine for the prevention of catheter-related bladder discomfort
Detailed description
After transurethral bladder resection, large-sized foley catheter have been used for drainage of urine and residual blood. Because of urinary catheterization, patients usually experiences catheter-related bladder discomfort defined as a burning sensation with an urge to void or discomfort in the supra-pubic region caused by catheter- related bladder irritation.
Dexmedetomidine is an alpha-2 antagonist and used as an analgesic agent. The investigators try to evaluate The efficacy of dexmedetomidine for the treatment of catheter-related bladder discomfort
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Drug: NS infusionNS infusion will be done during surgery. |
| Dex group | Experimental | Drug: Dex infusionDEX infusion will be done during surgery. |
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 resection
- ASA I-III
Key exclusion criteria (9 listed)
- Patient who disagrees to participate this investigation
- Patient with severe cardiovascular disease
- Patient with small-sized foley catheter (less than 18 Fr.)
- Patinets with any urinary tract obstructions
- Patient with hyperactive or neurogenic bladder
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 |
|---|---|---|
| Dex infusionDexmedetomidine will be injected (1 mcg/kg for 10 minutes and afterward 0.3 mcg/kg/hr) | Drug | Dex group |
| NS infusionNormal saline will be infused during surgery | Drug | Placebo group |
Primary outcome
The number of patients with catheter-related bladder discomfort
Time frame: at postoperative 1 hour
catheter-related bladder discomfort at postoperative 1 hour was evaluated as none, mild, moderate, severe. The number of patients with mild, moderate, severe discomfort will be calculated and compared between groups.
2 secondary outcomes
Catheter-related bladder discomfort
Time frame: at postoperative 0, 1, 6, 24 hours
Pain at suprapubic area
Time frame: at postoperative 0, 1, 6, 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2014.
- Derived from this study: PubMed 25485879Kim HC, Lee YH, Jeon YT, Hwang JW, Lim YJ, Park JE, Park HP. The effect of intraoperative dexmedetomidine on postoperative catheter-related bladder discomfort in patients undergoing transurethral bladder tumour resection: A double-blind randomised study. Eur J Anaesthesiol. 2015 Sep;32(9):596-601. doi: 10.1097/EJA.0000000000000196.
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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.
Hyun-Chang Kim, MD contact
Hee-Pyong Park, Ph.D contact
Hee-Pyoung Park principal investigator
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 Phase 4 study testing Dex infusion and NS infusion in people with Pain and Blood Pressure, 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 9 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: status not confirmed, as of the sponsor's last update on 19 Mar 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyun-Chang Kim, MD (onidori1979@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients with catheter-related bladder discomfort (time frame: at postoperative 1 hour). 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 NCT01991223, 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 19 Mar 2014.