Lidocaine Combined With Sufentanil for Preventing Catheter-related Bladder Discomfort

NCT05957653 | Unknown Phase 4

• 1 other identifier: IIT-2023-0092
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to evaluate the incidence and severity of postoperative catheter-related bladder discomfort after robot-assisted radical prostatectomy. The main question it aims to answer is to evaluate incidence of CRBD immediately after extubation in resuscitation. A total of 20ml of 2% lidocaine and 1μg/ml sufentanil or 20ml normal saline was injected into the bladder of the participants through the catheter. After drug injection, the catheter was clamped for 20 minutes, and then 100ml normal saline was injected into the bladder through the catheter to flush out. Then, the incidence of CRBD was compared between the two groups.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• incidence of CRBD

  incidence of CRBD

  immediately after extubation in resuscitation

Study Arms (2)

Lidocaine + sufentanil intervention group

EXPERIMENTAL

Drug: lidocaine and sufentanil

Saline control group

PLACEBO COMPARATOR

Drug: Saline

Interventions

lidocaine and sufentanil DRUG

A total of 20ml of 2% lidocaine and 1μg/ml sufentanil was injected into the bladder through the catheter.

Lidocaine + sufentanil intervention group

Saline DRUG

A total of 20ml normal saline was injected into the bladder through the catheter.

Saline control group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18-79 years, ASA class I-II
• participants undergoing robot-assisted radical prostatectomy under general anesthesia
• signed informed consent and volunteered to participate in the experiment

You may not qualify if:

• urethral stricture, difficulty in inserting catheter or urethral bleeding during catheterization
• a preexisting bladder disease such as an overactive bladder, bladder outflow obstruction, and neurogenic bladder
• cognitive impairment or communication disorders
• severe heart, lung, liver, kidney and immune system diseases
• confirmed or suspected allergy to this trial drug

Sponsors & Collaborators

• RenJi Hospital: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Lidocaine; Sufentanil; Sodium Chloride

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Hao Zhu

CONTACT

008602168383702; zhuhaossmu@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending physician

Study Record Dates

• First Submitted: July 15, 2023
• First Posted: July 24, 2023
• Study Start: October 7, 2023
• Primary Completion: September 30, 2025
• Study Completion: October 30, 2025
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share