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

NCT05510986 | Unknown DMC

• 1 other identifier: lingzi-2022-1
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

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.

Conditions

Effect of Drug; Adverse Effect of Opioids

Keywords

Oxycodone Hydrochloride; CRBD; TURBT; general anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 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

  1 hour

Secondary Outcomes (4)

• The incidence of Nausea and vomiting

  1 hour

• Degree of sedation

  1 hour

• Degree of pain

  1 hour

• the incidence of other complication

  1 hour

Study Arms (2)

Fentanyl group

ACTIVE COMPARATOR

Drugs

Drug: Fentanyl group

Oxycodone Hydrochloride group

EXPERIMENTAL

Drugs

Drug: Oxycodone Hydrochloride group

Interventions

Fentanyl group DRUG

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.

Also known as: Active Comparator

Fentanyl group

Oxycodone Hydrochloride group DRUG

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.

Also known as: Experimental

Oxycodone Hydrochloride group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

Study Sites (1)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 75004, China

Location

Study Officials

• Ni xinli, MD

  General Hospital of Ningxia Medical University

  STUDY CHAIR

Central Study Contacts

Ni xinli, MD

CONTACT

13014260603; eleven87670@163.com

Yin lingzi, MD

CONTACT

13014260603; eleven87670@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 22, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: November 1, 2024
• Last Updated: August 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)