Prostate Cancer
Conditions
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.
Interventions
DRUGlidocaine and sufentanil
A total of 20ml of 2% lidocaine and 1μg/ml sufentanil was injected into the bladder through the catheter.
DRUGSaline
A total of 20ml normal saline was injected into the bladder through the catheter.
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of CRBD | immediately after extubation in resuscitation | incidence of CRBD |
Contacts
Primary ContactHao Zhu
Outcome results
None listed