Lidocaine Combined With Sufentanil for Preventing Catheter-related Bladder Discomfort After Robot-assisted Radical Prostatectomy: a Randomized, Double-blind, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 140
- 主要终点
- incidence of CRBD
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Lidocaine + sufentanil intervention group
干预措施: lidocaine and sufentanil (Drug)
Saline control group
干预措施: Saline (Drug)
结局指标
主要结局
incidence of CRBD
时间窗: immediately after extubation in resuscitation
incidence of CRBD
次要结局
未报告次要终点