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Trial Title:
Lidocaine Combined With Sufentanil for Preventing Catheter-related Bladder Discomfort
NCT ID:
NCT05957653
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Lidocaine
Sufentanil
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
lidocaine and sufentanil
Description:
A total of 20ml of 2% lidocaine and 1μg/ml sufentanil was injected into the bladder
through the catheter.
Arm group label:
Lidocaine + sufentanil intervention group
Intervention type:
Drug
Intervention name:
Saline
Description:
A total of 20ml normal saline was injected into the bladder through the catheter.
Arm group label:
Saline control group
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.
Criteria for eligibility:
Criteria:
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
Gender:
Male
Minimum age:
18 Years
Maximum age:
79 Years
Healthy volunteers:
No
Start date:
October 7, 2023
Completion date:
October 30, 2025
Lead sponsor:
Agency:
RenJi Hospital
Agency class:
Other
Source:
RenJi Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05957653
