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

Effect of Drug Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05510986
• Other study ID #: lingzi-2022-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: November 1, 2024

Study information

• Verified date: August 2022
• Source: General Hospital of Ningxia Medical University
• Contact: Ni xinli, MD
• Phone: 13014260603
• Email: eleven87670[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 196
• Est. completion date: November 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Effect of Drug

Intervention

Drug:
• Fentanyl group
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 group
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.

Locations

Country	Name	City	State
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Ningxia Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Degree of sedation	Ramsay evaluation	1 hour
Secondary	Degree of pain	NRS	1 hour
Secondary	the incidence of other complication	Respiratory depression, itching, shivering	1 hour