Catheter Related Bladder DiscomfortPhase 4NCT03147066
Dezocine for Prevention of Catheter-related Bladder Discomfort
A Phase 4 study testing Dezocine and Flurbiprofen Axetil in people with Catheter Related Bladder Discomfort, run by Jian-jun Yang at 1 site in China.
Trial summary
This study evaluates the efficacy of dezocine in preventing the catheter-related bladder discomfort (CRBD) in a postanesthesia care unit (PACU). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Catheter Related Bladder Discomfort
- What is being tested?
- Dezocine and Flurbiprofen Axetil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 30 Oct 2017
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (>/=18)
- Male or female
- Patients scheduled for abdominal surgery
- Undergoing catheterization
- Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2
Who cannot join
- Patient with bladder outflow obstruction
- Patient with overactive bladder (frequency greater than three times per night or more than eight times per 24 h)
- Patient with multisystemic diseases (central nervous system, cardiovascular system hepatic, psychiatric, and end-stage renal diseases)
- Patient with chemical substance abuse
- Patient with chronic pain
- Patient with morbid obesity
- Patient needs for urgent intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Dezocine for the Prevention of Catheter-related Bladder Discomfort
This study evaluates the efficacy of dezocine in preventing the catheter-related bladder discomfort (CRBD) in a postanesthesia care unit (PACU).
Read the detailed description
Thirty min before the end of the surgery, patients were randomly assigned to one of the two group to receive intravenous dezocine 0.1 mg/kg (Group D, n=48) or flurbiprofen axetil 1 mg/kg (Group F, n=48) . The CRBD was assessed at 0, 1, 2, and 6 h after patient's arrival in the post-anaesthesia care unit. Severity of CRBD was graded as none, mild, moderate and severe.
- Conditions
- Catheter Related Bladder Discomfort
- Being tested
- Dezocine, Flurbiprofen Axetil
- Keywords
- Dezocine, CRBD, General anesthesia, Urinary catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DezocineDrug
Also called Dalgan
Dezocine (0.1 mg/kg）will be infused during surgery
Flurbiprofen AxetilDrug
Flurbiprofen Axetil (1 mg/kg）will be infused during surgery
| Study group | Role | What they receive |
|---|---|---|
| Dezocine | Experimental | 0.1 mg/kg of intravenous dezocine 30 min before the end of surgery Receives: Drug: Dezocine |
| Flurbiprofen axetil | Active comparator | 1 mg/kg of intravenous flurbiprofen axetil 30 min before the end of surgery Receives: Drug: Flurbiprofen Axetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheter related bladder discomfort symptoms
CRBD will be evaluated with a 4 point scale (1; no discomfort, 2; mild, revealed on questioning only, 3; moderate, stated by the patient without questioning, 4; severe, urinary urgency executed by behavioral responses, such as attempts to remove urinary catheter, restless extremity movements, verbal responses)
Measured: at 1 hour after extubatio
Secondary outcomes (4)
Catheter related bladder discomfort symptoms
CRBD will be evaluated with a 4 point scale (1; no discomfort, 2; mild, revealed on questioning only, 3; moderate, stated by the patient without questioning, 4; severe, urinary urgency executed by behavioral responses, such as attempts to remove urinary catheter, restless extremity movements, verbal responses)
Measured: at 0, 1, 2, and 6 hours after extubation
Severity of pain at suprapubic area
Pain at suprapubic area will be evaluated using VAS after extubation
Measured: at 0, 1, 2, and 6 hours after extubation
Sedation level
The Ramsay Sedation Scale was measured
Measured: at 0, 1, 2, and 6 hours after extubation
Incidence of treatment-emergent adverse events
The incidence of nausea, vomiting, hypotension, hypertension, bradycardia,respiratory depression after extubation, and excessive sedation were also recorded
Measured: at 0, 1, 2, and 6 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start1 Sep 2017
- Primary completion30 Oct 2017
- Study completion30 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter Related Bladder DiscomfortStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jian-jun Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jian-jun Yang, Zhongda Hospital
- Investigators
- Jian-jun Yang, PhD, Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147066
- Sponsor's protocol ID
- 20170110
- Status last verified
- Aug 2017
- First submitted
- 2 May 2017
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dezocine for the Prevention of Catheter-related Bladder Discomfort
- ClinicalTrials.gov ID
- NCT03147066
- Acronym / sponsor ID
- 20170110
- Conditions
- Catheter Related Bladder Discomfort
- Keywords
- Dezocine, CRBD, General anesthesia, Urinary catheter
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Jian-jun YangUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 10 May 2017 (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.
This study evaluates the efficacy of dezocine in preventing the catheter-related bladder discomfort (CRBD) in a postanesthesia care unit (PACU).
Detailed description
Thirty min before the end of the surgery, patients were randomly assigned to one of the two group to receive intravenous dezocine 0.1 mg/kg (Group D, n=48) or flurbiprofen axetil 1 mg/kg (Group F, n=48) . The CRBD was assessed at 0, 1, 2, and 6 h after patient's arrival in the post-anaesthesia care unit. Severity of CRBD was graded as none, mild, moderate and severe.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dezocine | Experimental | Drug: Dezocine0.1 mg/kg of intravenous dezocine 30 min before the end of surgery |
| Flurbiprofen axetil | Active comparator | Drug: Flurbiprofen Axetil1 mg/kg of intravenous flurbiprofen axetil 30 min before the end of surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult (>/=18)
- Male or female
- Patients scheduled for abdominal surgery
- Undergoing catheterization
- Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2
Key exclusion criteria (7 listed)
- Patient with bladder outflow obstruction
- Patient with overactive bladder (frequency greater than three times per night or more than eight times per 24 h)
- Patient with multisystemic diseases (central nervous system, cardiovascular system hepatic, psychiatric, and end-stage renal diseases)
- Patient with chemical substance abuse
- Patient with chronic pain
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 |
|---|---|---|
| DezocineAlso: DalganDezocine (0.1 mg/kg）will be infused during surgery | Drug | Dezocine |
| Flurbiprofen AxetilFlurbiprofen Axetil (1 mg/kg）will be infused during surgery | Drug | Flurbiprofen axetil |
Primary outcome
Catheter related bladder discomfort symptoms
Time frame: at 1 hour after extubatio
CRBD will be evaluated with a 4 point scale (1; no discomfort, 2; mild, revealed on questioning only, 3; moderate, stated by the patient without questioning, 4; severe, urinary urgency executed by behavioral responses, such as attempts to remove urinary catheter, restless extremity movements, verbal responses)
4 secondary outcomes
Catheter related bladder discomfort symptoms
Time frame: at 0, 1, 2, and 6 hours after extubation
Severity of pain at suprapubic area
Time frame: at 0, 1, 2, and 6 hours after extubation
Sedation level
Time frame: at 0, 1, 2, and 6 hours after extubation
Incidence of treatment-emergent adverse events
Time frame: at 0, 1, 2, and 6 hours after extubation
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 31 Oct 2017.
- Individual participant dataSharing planned: No
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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.
Jian-jun Yang, PhD principal investigator
Zhongda 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 Dezocine and Flurbiprofen Axetil in people with Catheter Related Bladder Discomfort, run by Jian-jun Yang at 1 site in China.
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 5 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 31 Oct 2017. 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 China. 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.
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?
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 symptoms (time frame: at 1 hour after extubatio). 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 31 Oct 2017; AzTrials last refreshed its copy on 7 Nov 2026.