Bladder IrritableNCT05013320
Combined Dexmedetomidine and Glycopyrrolate Therapy
A study testing Glycopyrrolate + dexmedetomidine and Dexmedetomidine in people with Bladder Irritable, run by Kangbuk Samsung Hospital.
Trial summary
Catheter-related bladder discomfort after transurethral resection of bladder tumor is frequent because of indwelling urinary catheter for irrigation. The mechanism of the catheter-related bladder discomfort is similar to that of overactive bladder, in which muscarinic acetylcholine receptors are stimulated. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Bladder Irritable
- What is being tested?
- Glycopyrrolate + dexmedetomidine and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 31 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical status I and II
- elective transurethral resection of bladder tumor under general anesthesia
Who cannot join
- arrhythmia
- bladder outflow obstruction
- overacitve bladder
- end stage renal disease
- neurogenic bladder
- morbid obesity
- psychiatric disorder
About this study
Official title: Combined Dexmedetomidine and Glycopyrrolate Therapy for Prevention of Catheter Related Bladder Discomfort After Transurethral Bladder Surgery
Catheter-related bladder discomfort after transurethral resection of bladder tumor is frequent because of indwelling urinary catheter for irrigation. The mechanism of the catheter-related bladder discomfort is similar to that of overactive bladder, in which muscarinic acetylcholine receptors are stimulated. The catheter-related bladder discomfort is a well known predisposing factor for emergence delirium after general anesthesia. In this study, we aimed to compare the incidence of catheter-related bladder discomfort between dexmedetomidine only therapy and combind dexmedetomidine and glycopyrrolate therapy.
- Conditions
- Bladder Irritable
- Being tested
- Glycopyrrolate + dexmedetomidine, Dexmedetomidine
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycopyrrolate + dexmedetomidineDrug
Intravenous glycopyrrolate before anesthetic induction. Dexmedetomidine administration during the surgery.
DexmedetomidineDrug
Dexmedetomidine administration during the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine only | Active comparator | dexmedetomidine is administered during the surgery Receives: Drug: Dexmedetomidine |
| Combined dexmedetomidine and glycopyrrolate | Experimental | glycopyrrolate and dexmedetomidine are administered during the surgery Receives: Drug: Glycopyrrolate + dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of catheter-related bladder discomfort
No = not complaining of bladder discomfort on asking; Mild = report discomfot only on questioning; Moderate: report without questioning without behavior responses; Severe = report without questioniing accompanied by behavior responses. Mild, Moderate, Severe bladder discomfort is defined to have catheter-related bladder discomfort
Measured: 0 minute after entering the post-anesthetic care unit
Secondary outcomes (6)
Emergence agitation
(1)calm (2)slightly agitated but consolable (3)moderately agitated and inconsolable (4)severely agitated and highly inconsolable
Measured: 0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit
Delirium
(1)acute and fluctuating changes in mental status (2)inattention (3)disorganized or incoherent thinking (4)altered level of consciousness. (1),(2) and (3), (1),(2), and (4), or (1)(2)(3)and (4) are defined to have deilrium.
Measured: 0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit
Postoperative pain
numerical rating scale (0=no pain to 10=worst pain imaginable)
Measured: 0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit
Sedation score
(1)anxious, agitated or restless (2)cooperative, oriented and trranquil (3)responds to commands, asleep (4)brisk response to light glabellar taps or oud noise (5)sluggish response to light glabellar taps or loud noise (6)noresponse
Measured: 0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit
Dry mouth
yes or no
Measured: 0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit
postoperative nausea and vomiting
yes or no
Measured: 0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start1 Sep 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Why it stopped: We could not get the IRB approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder IrritableStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kangbuk Samsung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eunah Cho, MD, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013320
- Sponsor's protocol ID
- DEXLYCO
- Status last verified
- Aug 2021
- First submitted
- 13 May 2021
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Dexmedetomidine and Glycopyrrolate Therapy for Prevention of Catheter Related Bladder Discomfort After Transurethral Bladder Surgery
- ClinicalTrials.gov ID
- NCT05013320
- Acronym / sponsor ID
- DEXLYCO
- Conditions
- Bladder Irritable
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We could not get the IRB approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 19 Aug 2021 (actual)
- 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.
Catheter-related bladder discomfort after transurethral resection of bladder tumor is frequent because of indwelling urinary catheter for irrigation. The mechanism of the catheter-related bladder discomfort is similar to that of overactive bladder, in which muscarinic acetylcholine receptors are stimulated. The catheter-related bladder discomfort is a well known predisposing factor for emergence delirium after general anesthesia. In this study, we aimed to compare the incidence of catheter-related bladder discomfort between dexmedetomidine only therapy and combind dexmedetomidine and glycopyrrolate therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine only | Active comparator | Drug: Dexmedetomidinedexmedetomidine is administered during the surgery |
| Combined dexmedetomidine and glycopyrrolate | Experimental | Drug: Glycopyrrolate + dexmedetomidineglycopyrrolate and dexmedetomidine are administered during the surgery |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical status I and II
- elective transurethral resection of bladder tumor under general anesthesia
Key exclusion criteria (7 listed)
- arrhythmia
- bladder outflow obstruction
- overacitve bladder
- end stage renal disease
- 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 |
|---|---|---|
| Glycopyrrolate + dexmedetomidineIntravenous glycopyrrolate before anesthetic induction. Dexmedetomidine administration during the surgery. | Drug | Combined dexmedetomidine and glycopyrrolate |
| DexmedetomidineDexmedetomidine administration during the surgery. | Drug | Dexmedetomidine only |
Primary outcome
The incidence of catheter-related bladder discomfort
Time frame: 0 minute after entering the post-anesthetic care unit
No = not complaining of bladder discomfort on asking; Mild = report discomfot only on questioning; Moderate: report without questioning without behavior responses; Severe = report without questioniing accompanied by behavior responses. Mild, Moderate, Severe bladder discomfort is defined to have catheter-related bladder discomfort
6 secondary outcomes
Emergence agitation
Time frame: 0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit
Delirium
Time frame: 0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit
Postoperative pain
Time frame: 0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit
Sedation score
Time frame: 0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit
Dry mouth
Time frame: 0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit
postoperative nausea and vomiting
Time frame: 0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Glycopyrrolate + dexmedetomidine and Dexmedetomidine in people with Bladder Irritable, run by Kangbuk Samsung Hospital.
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: withdrawn, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
The incidence of catheter-related bladder discomfort (time frame: 0 minute after entering the post-anesthetic care unit). 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 19 Aug 2021.