Onset Time of Thiopental Versus Propofol in the Elderly
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- "Onset-time" defined as the time from started induction bolus to: - Time to BIS-value <50.
研究概览
简要总结
This study is aimed at increasing the safety of the use of anaesthesia in an elderly population (> 60 years). Patients with decreased physiological reserve, including all elderly patients, have an increased risk of getting an erroneous induction bolus. This project will investigate how fast elderly patients (> 60 years) fall asleep during bolus induction of anaesthesia with two of the most used hypnotics, thiopental and propofol, evaluated with BIS-monitoring and clinical signs of anaesthetic depth. The hemodynamic response will also be evaluated.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective surgical patients above 60 years of age, with an indication of general anaesthesia during surgery.
- •Informed consent.
- •The patient must be legally competent.
- •The patient must be able to read and understand Danish.
排除标准
- •Known allergic reactions to thiopental, propofol, lidocaine or alfentanil
- •"Body Mass Index" (BMI) <18 and >
- •NYHA-class > 2.
研究组 & 干预措施
Thiopental
Thiopental for induction of anaesthesia.
干预措施: Thiopental (Drug)
Propofol
Propofol for induction of anaesthesia.
干预措施: Propofol (Drug)
结局指标
主要结局
"Onset-time" defined as the time from started induction bolus to: - Time to BIS-value <50.
时间窗: 120 seconds
次要结局
- Hemodynamical effect (bloodpressure/pulse) every 60 seconds.(120 seconds)
- "Onset-time" defined as the time from started induction bolus to: - Time to loss of grip.(120 seconds)
- "Onset-time" defined as the time from started induction bolus to: - Time to eye closure.(120 seconds)
- "Onset-time" defined as the time from started induction bolus to: - Time to ciliary reflex cessation.(120 seconds)