The Effect of Propofol on Dexamethasone-induced Perineal Pruritus
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- visual analogue scale(VAS) scores
研究概览
简要总结
patients may appear serious perineal itching, after injection of dexamethasone sodium phosphate injection its incidence is about 25% ~ 100%, and the incidence of the discomfort in females was much higher than that of the maleTo investigate the effect of propofol pretreatment on perineal pruritus induced by dexamethasone sodium phosphate injection and explore the possible machanisms.
详细描述
40 patients scheduled for selective surgery,aged 18-65years,ASA physical status I~II,BMI 18~30kg/m2 were selected in this study.The patients were equally randomized into two groups: propofol (P) group and normal saline (N) group, 20 cases in each group. Before anesthesia induction, M group received intravenous injection of 0.3mg/kg propofol , while N group received corresponding intravenous normal saline of the same volume. After 1 min, both groups received intravenous injection of dexamethasone sodium phosphate injection of 10mg. The anesthesiologist assessed perineal irritation in both groups and recorded Ramsay scores,the number of cases, visual analogue scale(VAS) scores ,duration of itching and observed the occurrence of adverse reactions such as dizziness, hypotension and respiratory depression in 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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Elective female surgery patients, ages 18 to 65 years old, ASA Ⅰ or Ⅱ level, body mass index (BMI) of 18 ~ 30 kg/m2.
排除标准
- •diabetes mellitus, paresthesia, allergy to narcotic drugs, routine preoperative use of narcotic analgesics, long-term use of hormones, drug and alcohol abuse, communication disorders in psychiatric disorders, pregnancy or lactation, and patients with severe systemic diseases and unwilling to undergo the trial.
研究组 & 干预措施
normal saline (N) group
Before anesthesia induction, N group received corresponding intravenous normal saline of the same volume.
干预措施: normal saline (Drug)
propofol (P) group
Before anesthesia induction, P group received intravenous injection of 0.3mg/kg propofol
干预措施: Propofol (Drug)
结局指标
主要结局
visual analogue scale(VAS) scores
时间窗: in 3min
VAS score was used to grade the degree of perineal itching: VAS 0 was no discomfort, 1-3 was mild, 4-6 was moderate, and 7-10 was severe
次要结局
- the occurrence of adverse reactions(in 3min)
研究者
Ma Hong
Affiliated hospital of Yangzhou university
Yangzhou University