The Effect of Oxycodone Hydrochloride on CRBD After TURBT Under General Anesthesia
The Effect of Oxycodone Hydrochloride on Catheter-related Bladder Discomfort After TURBT Under General Anesthesia
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ni xinli, MD
- Phone Number: 13014260603
- Email: eleven87670@163.com
Study Contact Backup
- Name: Yin lingzi, MD
- Phone Number: 13014260603
- Email: eleven87670@163.com
Study Locations
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Ningxia
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Yinchuan, Ningxia, China, 75004
- General Hospital of Ningxia Medical University
-
Contact:
- lingzi yin, M.D.
- Email: eleven87670@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Fentanyl group
Drugs
|
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.
Other Names:
|
|
Experimental: Oxycodone Hydrochloride group
Drugs
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The incidence of Nausea and vomiting
Time Frame: 1 hour
|
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
|
1 hour
|
|
Degree of sedation
Time Frame: 1 hour
|
Ramsay evaluation
|
1 hour
|
|
Degree of pain
Time Frame: 1 hour
|
NRS
|
1 hour
|
|
the incidence of other complication
Time Frame: 1 hour
|
Respiratory depression, itching, shivering
|
1 hour
|
Collaborators and Investigators
Investigators
- Study Chair: Ni xinli, MD, General Hospital of Ningxia Medical University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- lingzi-2022-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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