Effect of DrugNCT05510986
The Effect of Oxycodone Hydrochloride on CRBD After TURBT Under General Anesthesia
A study testing Fentanyl group and Oxycodone Hydrochloride group in people with Effect of Drug and Adverse Effect of Opioids, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial summary
The purpose of this study is to investigate the effect of Oxycodone Hydrochloride on catheter-related bladder discomfort in patients undergoing transurethral resection of bladder tumor after general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Effect of Drug, Adverse Effect of Opioids
- What is being tested?
- Fentanyl group and Oxycodone Hydrochloride group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 1 Nov 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- More than 18 years old;
- ASA I - III;
- Plan to perform transurethral resection of bladder tumor under general anesthesia; (
- Agree to participate in this study and sign the informed consent form.
Who cannot join
- Refuse to participate in this study;
- Emergency surgery;
- Catheter was indwelling before operation;
- Taking opioids for a long time before operation;
- Previous history of schizophrenia, epilepsy, Parkinson's disease or myasthenia gravis;
- Unable to communicate due to coma, severe dementia or language disorder before operation;
- Critical condition (ASA grade ≥ IV before operation); Severe renal function damage (requiring renal replacement therapy); Severe liver function damage (child Pugh grade C); Acute stage of chronic obstructive pulmonary disease, severe asthma, severe pulmonary heart disease;
- History of opioid allergy.
Trial locations and contacts
1 site in 1 country.
China1 site
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 75004
Xinli Ni, Dr., xinlini6@nyfy.com.cn
lingzi yin, M.D., eleven87670@163.com
About this study
Official title: The Effect of Oxycodone Hydrochloride on Catheter-related Bladder Discomfort After TURBT Under General Anesthesia
The purpose of this study is to investigate the effect of Oxycodone Hydrochloride on catheter-related bladder discomfort in patients undergoing transurethral resection of bladder tumor after general anesthesia.
Read the detailed description
Catheter-related bladder discomfort(CRBD) is a frequent complication after indwelling catheter under general anesthesia. The incidence of CRBD in patients undergoing Transurethral resection is as high as 66.7-91.2%.CRBD may lead some poor prognosis including postoperative restlessness, bleeding, and circulatory instability.therefore，how to reduce the incidence of CRBD is one of the urgent problems to be solved in clinic.
Oxycodone Hydrochloride is a strong opioid receptor agonist used in clinic at present. It has certain advantages in the regulation of visceral pain and can produce analgesic effect without causing restlessness, gastrointestinal motility inhibition and respiratory inhibition through stimulating the μ and κ opioid receptor simultaneously. However, the effect of Oxycodone Hydrochloride on catheter-related bladder discomfort in patients undergoing transurethral resection of bladder tumor after general anesthesia is still unknown. The purpose of this study is to explore whether Oxycodone Hydrochloride via intravenous injection could reduce the incidence of CRBD in patients undergoing transurethral resection of bladder tumor after general anesthesia and could not increase other complications during the recovery period of general anesthesiathe.
- Conditions
- Effect of Drug, Adverse Effect of Opioids
- Being tested
- Fentanyl group, Oxycodone Hydrochloride group
- Keywords
- Oxycodone Hydrochloride, CRBD, TURBT, general anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl groupDrug
Also called Active Comparator
Dilute fentanyl hydrochloride injection (1ml:0.1mg) with 0.9% normal saline to 10μg/ml, 1μg/kg fentanyl is slowly injected intravenously 10 minutes before the end of the operation, and the administration speed is not less than 5 minutes.
Oxycodone Hydrochloride groupDrug
Also called Experimental
Dilute Oxycodone Hydrochloride injection (1ml:10mg) with 0.9% normal saline to
1mg/ml, 0.1mg/kg Oxycodone Hydrochloride is slowly injected intravenously 10 minutes before the end of the operation, and the administration speed is not less than 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl group | Active comparator | Drugs Receives: Drug: Fentanyl group |
| Oxycodone Hydrochloride group | Experimental | Drugs Receives: Drug: Oxycodone Hydrochloride group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of catheter-related bladder discomfort
CRBD is symptoms vary among patients from burning sensation and pain in the suprapubic and penile areas to urinary urgency.
4 grades 0:No discomfort
- Mild discomfort only reported upon questioning
- Moderate discomfort, urge to pass urine reported by the patient without questioning
- Severe discomfort, urge to pass urine accompanied by behavioral responses, such as flailing limbs, strong verbal responses, or attempt to pull out the catheter
Measured: 1 hour
Secondary outcomes (4)
The incidence of Nausea and vomiting
Nausea refers to patients who have gastrointestinal symptoms but do not spit out stomach contents. Vomiting means that the patient has gastrointestinal symptoms and vomits stomach contents
Measured: 1 hour
Degree of sedation
Ramsay evaluation
Measured: 1 hour
Degree of pain
NRS
Measured: 1 hour
the incidence of other complication
Respiratory depression, itching, shivering
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of DrugStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ni xinli, MD, Study chair, General Hospital of Ningxia Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510986
- Sponsor's protocol ID
- lingzi-2022-1
- Status last verified
- Aug 2022
- First submitted
- 2 Aug 2022
- Last updated
- 22 Aug 2022
- 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 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oxycodone Hydrochloride on Catheter-related Bladder Discomfort After TURBT Under General Anesthesia
- ClinicalTrials.gov ID
- NCT05510986
- Acronym / sponsor ID
- lingzi-2022-1
- Conditions
- Effect of Drug, Adverse Effect of Opioids
- Keywords
- Oxycodone Hydrochloride, CRBD, TURBT, general anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 22 Aug 2022 (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.
The purpose of this study is to investigate the effect of Oxycodone Hydrochloride on catheter-related bladder discomfort in patients undergoing transurethral resection of bladder tumor after general anesthesia.
Detailed description
Catheter-related bladder discomfort(CRBD) is a frequent complication after indwelling catheter under general anesthesia. The incidence of CRBD in patients undergoing Transurethral resection is as high as 66.7-91.2%.CRBD may lead some poor prognosis including postoperative restlessness, bleeding, and circulatory instability.therefore，how to reduce the incidence of CRBD is one of the urgent problems to be solved in clinic.
Oxycodone Hydrochloride is a strong opioid receptor agonist used in clinic at present. It has certain advantages in the regulation of visceral pain and can produce analgesic effect without causing restlessness, gastrointestinal motility inhibition and respiratory inhibition through stimulating the μ and κ opioid receptor simultaneously. However, the effect of Oxycodone Hydrochloride on catheter-related bladder discomfort in patients undergoing transurethral resection of bladder tumor after general anesthesia is still unknown. The purpose of this study is to explore whether Oxycodone Hydrochloride via intravenous injection could reduce the incidence of CRBD in patients undergoing transurethral resection of bladder tumor after general anesthesia and could not increase other complications during the recovery period of general anesthesiathe.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl group | Active comparator | Drug: Fentanyl groupDrugs |
| Oxycodone Hydrochloride group | Experimental | Drug: Oxycodone Hydrochloride groupDrugs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- More than 18 years old;
- ASA I - III;
- Plan to perform transurethral resection of bladder tumor under general anesthesia; (
- Agree to participate in this study and sign the informed consent form.
Key exclusion criteria (8 listed)
- Refuse to participate in this study;
- Emergency surgery;
- Catheter was indwelling before operation;
- Taking opioids for a long time before operation;
- Previous history of schizophrenia, epilepsy, Parkinson's disease or myasthenia gravis;
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 |
|---|---|---|
| Fentanyl groupAlso: Active ComparatorDilute fentanyl hydrochloride injection (1ml:0.1mg) with 0.9% normal saline to 10μg/ml, 1μg/kg fentanyl is slowly injected intravenously 10 minutes before the end of the operation, and the administration speed is not less than 5 minutes. | Drug | Fentanyl group |
| Oxycodone Hydrochloride groupAlso: ExperimentalDilute Oxycodone Hydrochloride injection (1ml:10mg) with 0.9% normal saline to 1mg/ml, 0.1mg/kg Oxycodone Hydrochloride is slowly injected intravenously 10 minutes before the end of the operation, and the administration speed is not less than 5 minutes. | Drug | Oxycodone Hydrochloride group |
Primary outcome
The incidence of catheter-related bladder discomfort
Time frame: 1 hour
CRBD is symptoms vary among patients from burning sensation and pain in the suprapubic and penile areas to urinary urgency. 4 grades 0:No discomfort 1. Mild discomfort only reported upon questioning 2. Moderate discomfort, urge to pass urine reported by the patient without questioning 3. Severe discomfort, urge to pass urine accompanied by behavioral responses, such as flailing limbs, strong verbal responses, or attempt to pull out the catheter
4 secondary outcomes
The incidence of Nausea and vomiting
Time frame: 1 hour
Degree of sedation
Time frame: 1 hour
Degree of pain
Time frame: 1 hour
the incidence of other complication
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- 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.
Ni xinli, MD study chair
General Hospital of Ningxia Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl group and Oxycodone Hydrochloride group in people with Effect of Drug and Adverse Effect of Opioids, run by General Hospital of Ningxia Medical University 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 4 inclusion and 8 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 22 Aug 2022. 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.
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 Ni xinli, MD (13014260603, eleven87670@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of catheter-related bladder discomfort (time frame: 1 hour). 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 22 Aug 2022.