The efficacy of Trospium for prevention of catheter-related bladder discomfort: a prospective, randomized, placebo-controlled, double-blind study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence and severity of catheter related bladder discomfort
研究概览
简要总结
Postoperative urinary catheter related bladder discomfort (CRBD) can occasionally occur in patients who have undergone catheterization during surgery. Trospium is a non selective muscarinic receptor antagonist. It has been effective in prevention Over active bladder symptoms. As these symptoms are similar to catheter related discomfort, this drug may have beneficial role in CRBD.
All selected patients will be randomized into 2 groups (30 in each group) depending on the drug given -
Group T - Patients will be received Trospium 60 mg orally 1 hr before the inducion of anesthesia
Group C - Patients will be received placebo 1 hr before the induction of anesthesia
Primary Outcome - Incidence and severity of catheter related bladder discomfort
Secondary Outcome - Any complication like PONV, facial flushing, dry mouth, blurred vision and abdominal discomfort
Statistical analysis will be done after completion of study
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age group 20-60 years 2.ASA grade I and II, 3.Requiring urinary Cathetrization.
排除标准
- •1.Patients with known sensitivity to study drug, 2.History of drug or alcohol abuse, 3.History of chronic pain or daily intake of analgesics, 4.Pregnant or breast-feeding females, 5.Uncontrolled medical disease (diabetes mellitus and hypertension) 6.Impaired kidney or liver functions and 7.Psychiatric patients.
结局指标
主要结局
Incidence and severity of catheter related bladder discomfort
时间窗: On arrival in the post anesthesia care unit(0 hr) and again at 1, 2, and 6 hr later
次要结局
- Any complication like postoperative nausea vomiting, facial flushing, dry mouth, blurred vision and abdominal discomfort(During postoperative period)