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

NCT ID: NCT05510986

Last Updated: 2022-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-11-01

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.

Conditions

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Effect of Drug Adverse Effect of Opioids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Fentanyl group

Drugs

Group Type ACTIVE_COMPARATOR

Fentanyl group

Intervention Type 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.

Oxycodone Hydrochloride group

Drugs

Group Type EXPERIMENTAL

Oxycodone Hydrochloride group

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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Active Comparator Experimental

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General Hospital of Ningxia Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ni xinli, MD

Role: STUDY_CHAIR

General Hospital of Ningxia Medical University

Locations

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General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Site Status

Countries

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China

Central Contacts

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Ni xinli, MD

Role: CONTACT

13014260603

Yin lingzi, MD

Role: CONTACT

13014260603

Facility Contacts

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Xinli Ni, Dr.

Role: primary

lingzi yin, M.D.

Role: backup

Other Identifiers

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lingzi-2022-1

Identifier Type: -

Identifier Source: org_study_id

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