Effects of Premedication by Midazolam on Preoperative Anxiety for Emergency Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- visual analog scale of anxiety
研究概览
简要总结
Preoperative anxiety is a subjective and painful experience and may have adverse psychological consequences and complicate anesthetic management. The aim of the study is to show the effect of premedication by midazolam on preoperative anxiety assessed by a visual analog scale and by measuring salivary cortisol levels. This study was a monocentric, prospective, blind randomized placebo controlled clinical study. Sixty patients, aged 18 to 79 years, to undergo elective surgery under general anesthesia with tracheal intubation must be enrolled and randomized to receive midazolam (0.02mg/kg) or placebo. The primary outcome is the reduction in anxiety assessed by a visual analog scale. The secondary outcomes are the reduction in salivary cortisol levels, the overall level of anxiety and the evaluation of respiratory and hemodynamic adverse effects of midazolam.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •major patient undergoing elective surgery under general anesthesia with tracheal intubation
- •Anesthesia state 1 and 2
- •preoperative fasting for 6 hours
- •information and signed consent
- •social security
- •non pregnant women
排除标准
- •anesthesia state above 3
- •midazolam sensibility
- •pregnant or breastfeeding women
- •ICU patients
- •no consent
- •pediatric surgery
- •no social security
- •no tracheal intubation
- •required premedication in placebo group or midazolam sensibility in premedication group
研究组 & 干预措施
Isotonic serum
placebo administration
干预措施: placebo administration (Drug)
Isotonic serum
placebo administration
干预措施: midazolam intravenous administration (Drug)
Midazolam
midazolam intravenous administration 0.02mg/kg
干预措施: placebo administration (Drug)
Midazolam
midazolam intravenous administration 0.02mg/kg
干预措施: midazolam intravenous administration (Drug)
结局指标
主要结局
visual analog scale of anxiety
时间窗: baseline, up to the end of support in recovery room
visual scale rated from 0 to 10 to describe the intensity of anxiety simple and reproducible measurement for a short period
次要结局
- Global anxiety(baseline)
- Intraoperative consumption of hypnotics and opioids(at anesthesia induction up to 10 minutes)
- Intubation score(after intubation)
- Adverse midazolam effects(baseline up to the end of support in recovery room)
- Patient's satisfaction(at the end of the support in recovery room)
- Comfort induction(at anesthesia induction)
- Output score of recovery room (Aldrete score)(at the end of support in recovery room)
- salivary cortisol level(baseline and at the entrance in operating room)