The Effects of Dezocine Pretreatment on Dexamethasone Induced Perineal Irritation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The occurrence of perineal irritation after the injection of dexamethasone 21-phosphate among Group D (40 patients receive dezocine 0.1 mg/Kg) and Group C (40 patients receive matching placebo)
研究概览
简要总结
The purpose of this study is to investigate the efficacy of dezocine pretreatment on dexamethasone 21-phosphate induced perineal irritation (include pian and pruritus).
详细描述
Dexamethasone is a synthetic glucocorticoid, which may cause perineal irritation when given intravenously. The major clinical manifestations are pruritus and pain，and the incidence vary between 38%-71%. Some patients undergo spontaneous remission, while others develop into severe pain or pruritus. Dezocine, a new synthetic opiate agonist-antagonist, has been used for the treatment of pain and pruritus, but its role in relieving dexamethasone induced perineal irritation has not been studied yet. The aim of this study was to investigate the efficacy of dezocine pretreatment on dexamethasone induced perineal irritation.
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
- Triple (Participant, Care Provider, 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
- •Aged 18-65 years
- •ASA physical status I-II
- •BMI 18-24.5 kg/m2
排除标准
- •On regular use of analgesic
- •Contraindication or allergy to steroid or dezocine
- •Drug or alcohol abuse
- •Diagnosed with paresthesia or mental diseases
- •Communication disorders
- •Pregnancy or nursing
研究组 & 干预措施
Group D
40 patients receive dezocine 0.1 mg/Kg
干预措施: dezocine (Drug)
Group C
40 patients receive matching placebo （normal saline）
干预措施: normal saline (Other)
结局指标
主要结局
The occurrence of perineal irritation after the injection of dexamethasone 21-phosphate among Group D (40 patients receive dezocine 0.1 mg/Kg) and Group C (40 patients receive matching placebo)
时间窗: In the first 3 min period after the injection of dexamethasone 21-phosphate phosphate
次要结局
- The severity of perineal irritation after the injection of dexamethasone 21-phosphate among Group D (40 patients receive dezocine 0.1 mg/Kg) and Group C (40 patients receive matching placebo)(In the first 3 min period after the injection of dexamethasone 21-phosphate phosphate)