Efficacy of Dezocine for the Prevention of Catheter-related Bladder Discomfort
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Catheter related bladder discomfort symptoms
研究概览
简要总结
This study evaluates the efficacy of dezocine in preventing the catheter-related bladder discomfort (CRBD) in a postanesthesia care unit (PACU).
详细描述
Thirty min before the end of the surgery, patients were randomly assigned to one of the two group to receive intravenous dezocine 0.1 mg/kg (Group D, n=48) or flurbiprofen axetil 1 mg/kg (Group F, n=48) . The CRBD was assessed at 0, 1, 2, and 6 h after patient's arrival in the post-anaesthesia care unit. Severity of CRBD was graded as none, mild, moderate and severe.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (>/=18)
- •Male or female
- •Patients scheduled for abdominal surgery
- •Undergoing catheterization
- •Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2
排除标准
- •Patient with bladder outflow obstruction
- •Patient with overactive bladder (frequency greater than three times per night or more than eight times per 24 h)
- •Patient with multisystemic diseases (central nervous system, cardiovascular system hepatic, psychiatric, and end-stage renal diseases)
- •Patient with chemical substance abuse
- •Patient with chronic pain
- •Patient with morbid obesity
- •Patient needs for urgent intervention
研究组 & 干预措施
Dezocine
0.1 mg/kg of intravenous dezocine 30 min before the end of surgery
干预措施: Dezocine (Drug)
Flurbiprofen axetil
1 mg/kg of intravenous flurbiprofen axetil 30 min before the end of surgery
干预措施: Flurbiprofen Axetil (Drug)
结局指标
主要结局
Catheter related bladder discomfort symptoms
时间窗: at 1 hour after extubatio
CRBD will be evaluated with a 4 point scale (1; no discomfort, 2; mild, revealed on questioning only, 3; moderate, stated by the patient without questioning, 4; severe, urinary urgency executed by behavioral responses, such as attempts to remove urinary catheter, restless extremity movements, verbal responses)
次要结局
- Catheter related bladder discomfort symptoms(at 0, 1, 2, and 6 hours after extubation)
- Severity of pain at suprapubic area(at 0, 1, 2, and 6 hours after extubation)
- Sedation level(at 0, 1, 2, and 6 hours after extubation)
- Incidence of treatment-emergent adverse events(at 0, 1, 2, and 6 hours after extubation)
研究者
Jian-jun Yang
Director, Department of Anesthesiology
Zhongda Hospital