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Lidocaine Combined With Sufentanil for Preventing Catheter-related Bladder Discomfort

Primary Purpose

Prostate Cancer

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
lidocaine and sufentanil
Saline
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prostate Cancer

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Lidocaine + sufentanil intervention group

    Saline control group

    Arm Description

    Outcomes

    Primary Outcome Measures

    incidence of CRBD
    incidence of CRBD

    Secondary Outcome Measures

    Full Information

    First Posted
    July 15, 2023
    Last Updated
    July 15, 2023
    Sponsor
    RenJi Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05957653
    Brief Title
    Lidocaine Combined With Sufentanil for Preventing Catheter-related Bladder Discomfort
    Official Title
    Lidocaine Combined With Sufentanil for Preventing Catheter-related Bladder Discomfort After Robot-assisted Radical Prostatectomy: a Randomized, Double-blind, Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 7, 2023 (Anticipated)
    Primary Completion Date
    September 30, 2025 (Anticipated)
    Study Completion Date
    October 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    RenJi Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    140 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Lidocaine + sufentanil intervention group
    Arm Type
    Experimental
    Arm Title
    Saline control group
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    lidocaine and sufentanil
    Intervention Description
    A total of 20ml of 2% lidocaine and 1μg/ml sufentanil was injected into the bladder through the catheter.
    Intervention Type
    Drug
    Intervention Name(s)
    Saline
    Intervention Description
    A total of 20ml normal saline was injected into the bladder through the catheter.
    Primary Outcome Measure Information:
    Title
    incidence of CRBD
    Description
    incidence of CRBD
    Time Frame
    immediately after extubation in resuscitation

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    79 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hao Zhu
    Phone
    008602168383702
    Email
    zhuhaossmu@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Lidocaine Combined With Sufentanil for Preventing Catheter-related Bladder Discomfort

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