The Effect of Oxycodone Hydrochloride on CRBD After TURBT Under General Anesthesia

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Oxycodone Hydrochloride on Catheter-related Bladder Discomfort After TURBT Under General Anesthesia

Conditions
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Effect of Drug, Adverse Effect of Opioids

Intervention / Treatment
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* Drug: Fentanyl group
* Drug: Oxycodone Hydrochloride group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fentanyl group<br>Drugs | Drug: Fentanyl group<br>* 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.<br>* Other names: Active Comparator;|
| Experimental: Oxycodone Hydrochloride group<br>Drugs | Drug: Oxycodone Hydrochloride group<br>* 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.<br>* Other names: Experimental;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 hour | 
| Degree of sedation | Ramsay evaluation | 1 hour | 
| Degree of pain | NRS | 1 hour | 
| the incidence of other complication | Respiratory depression, itching, shivering | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxycodone Hydrochloride, CRBD, TURBT, general anesthesia