Lidocaine Combined With Sufentanil for Preventing Catheter-related Bladder Discomfort

NCT ID: NCT05957653

Last Updated: 2023-07-24

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

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-07

Study Completion Date

2025-10-30

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lidocaine + sufentanil intervention group

Group Type EXPERIMENTAL

lidocaine and sufentanil

Intervention Type DRUG

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

Saline control group

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

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

Interventions

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lidocaine and sufentanil

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

Intervention Type DRUG

Saline

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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zhuhao

attending physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Hao Zhu

Role: CONTACT

008602168383702

Other Identifiers

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IIT-2023-0092

Identifier Type: -

Identifier Source: org_study_id

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