Lidocaine Combined With Sufentanil for Preventing Catheter-related Bladder Discomfort After Robot-assisted Radical Prostatectomy: a Randomized, Double-blind, Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- lidocaine and sufentanil
- Conditions
- Prostate Cancer
- Sponsor
- RenJi Hospital
- Enrollment
- 140
- Primary Endpoint
- incidence of CRBD
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
zhuhao
attending physician
RenJi Hospital
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
Arms & Interventions
Lidocaine + sufentanil intervention group
Intervention: lidocaine and sufentanil
Saline control group
Intervention: Saline
Outcomes
Primary Outcomes
incidence of CRBD
Time Frame: immediately after extubation in resuscitation
incidence of CRBD