Catheter Site DiscomfortNCT02228473
Effect of Glycopyrrolate and Atropine on Catheter-Related Bladder Discomfort
A study testing Glycopyrrolate and Atropine 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 glycopyrrolate and atropine 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?
- Glycopyrrolate and Atropine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2014to Mar 2015
- 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 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 atropine or glycopyrrolate
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University of Hospital
Seoul, Korea, Republic of
Hee-Pyoung Park, PhD, +82-10-2971-7647, hppark@snu.ac.kr
Hyun-Chang Kim, MD
About this study
Official title: Effect of Glycopyrrolate and Atropine as Adjuncts to Reversal of Non-Depolarizing Neuromuscular Blocking Agents on Postoperative Catheter-Related Bladder Discomfort
We want to evaluate the efficacy of the glycopyrrolate and atropine 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 adjuncts to reversal agents such as glycopyrrolate and atropine are known to block the muscarinic receptor in different ways.
We want to evaluate the efficacy of the glycopyrrolate and atropine for the prevention of catheter-related bladder discomfort.
- Being tested
- Glycopyrrolate, Atropine
- 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.
GlycopyrrolateDrug
Glycopyrrolate will be administered.
AtropineDrug
Atropine will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Glycopyrrolate | Experimental | Glycopyrrolate will be administered as the adjuncts of neuromuscular blocker reversal agent. Receives: Drug: Glycopyrrolate |
| Atropine | Active comparator | Atropine will be administered as the adjuncts of neuromuscular blocker reversal agent. Receives: Drug: Atropine |
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).
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).
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 posted29 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionFeb 2015 (estimated)
- Study completionMar 2015 (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 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
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hee-Pyoung Park, PhD, Principal investigator, Seoul National University of Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228473
- Sponsor's protocol ID
- CRBDGlycoAtr
- Status last verified
- Aug 2014
- First submitted
- 27 Aug 2014
- Last updated
- 28 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim HC, Lim SM, Seo H, Park HP. Effect of glycopyrrolate versus atropine coadministered with neostigmine for reversal of rocuronium on postoperative catheter-related bladder discomfort in patients undergoing transurethral resection of bladder tumor: a prospective randomized study. J Anesth. 2015 Dec;29(6):831-5. doi: 10.1007/s00540-015-2064-2. Epub 2015 Aug 9.
PubMed 26254585
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Glycopyrrolate and Atropine as Adjuncts to Reversal of Non-Depolarizing Neuromuscular Blocking Agents on Postoperative Catheter-Related Bladder Discomfort
- ClinicalTrials.gov ID
- NCT02228473
- Acronym / sponsor ID
- CRBDGlycoAtr
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 29 Aug 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 glycopyrrolate and atropine 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 adjuncts to reversal agents such as glycopyrrolate and atropine are known to block the muscarinic receptor in different ways.
We want to evaluate the efficacy of the glycopyrrolate and atropine 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 |
|---|---|---|
| Glycopyrrolate | Experimental | Drug: GlycopyrrolateGlycopyrrolate will be administered as the adjuncts of neuromuscular blocker reversal agent. |
| Atropine | Active comparator | Drug: AtropineAtropine will be administered as the adjuncts of neuromuscular blocker reversal 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 |
|---|---|---|
| GlycopyrrolateGlycopyrrolate will be administered. | Drug | Glycopyrrolate |
| AtropineAtropine will be administered. | Drug | Atropine |
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).
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2014.
- Derived from this study: PubMed 26254585Kim HC, Lim SM, Seo H, Park HP. Effect of glycopyrrolate versus atropine coadministered with neostigmine for reversal of rocuronium on postoperative catheter-related bladder discomfort in patients undergoing transurethral resection of bladder tumor: a prospective randomized study. J Anesth. 2015 Dec;29(6):831-5. doi: 10.1007/s00540-015-2064-2. Epub 2015 Aug 9.
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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 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 study testing Glycopyrrolate and Atropine 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: status not confirmed, as of the sponsor's last update on 28 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?
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 (82-10-2886-2876, onidori1979@gmail.com), or a site near the patient. 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?
On the ClinicalTrials.gov record for NCT02228473, 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 28 Oct 2014.