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

Not Applicable

Not yet recruiting

• Conditions: Effect of Drug; Adverse Effect of Opioids
• Interventions: Drug: Oxycodone Hydrochloride group; Drug: Fentanyl group

• Registration Number: NCT05510986
• Lead Sponsor: General Hospital of Ningxia Medical University

Brief 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.

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 Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-02
• Study First Submitted QC: 2022-08-18
• Last Update Submitted: 2022-08-18
• Study First Posted: 2022-08-22
• Last Update Posted: 2022-08-22
• Study Start: 2022-10-01
• Primary Completion: 2024-10-01
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 196

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxycodone Hydrochloride group	Oxycodone Hydrochloride group	Drugs
Fentanyl group	Fentanyl group	Drugs

Primary Outcome Measures

Name	Time	Method
The incidence of catheter-related bladder discomfort	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

Secondary Outcome Measures

Name	Time	Method
Degree of pain	1 hour	NRS
the incidence of other complication	1 hour	Respiratory depression, itching, shivering
The incidence of Nausea and vomiting	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
Degree of sedation	1 hour	Ramsay evaluation

Trial Locations

Locations (1)

General Hospital of Ningxia Medical University; 🇨🇳 Yinchuan, Ningxia, China