Influence of Anesthetics on Sedation and Antinociception: an Analysis of Auditory Evoked, Visceral Evoked and Heat Evoked Potentials
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- influence of different drugs on evoked responses
研究概览
简要总结
The aim of the present study is to investigate and quantify the influence of commonly used anesthetics on auditory and pain evoked potentials.
详细描述
During surgery patients are exposed to different auditory and sensory stimuli. In this study we investigate the influence of different anesthetics to alertness and nociception. In addition to auditory stimuli (AEP as a measure of sedation), Contact Heat Evoked Potential Stimuli (CHEPS), and esophageal evoked potentials from the lower 1/3 of the esophagus are measured to quantify the effects of anesthetics. 60 Volunteers are enrolled into this study. For each drug, three different levels are measured:
- level 1 no medication
- level 2 low dose of medication
- level 3 light sedation dose (volunteer responds to command)
Four drugs are measured in the study:
propofol, sevoflurane, S-ketamine and remifentanil.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists (ASA) physical status 1-2
排除标准
- •drugs that effect the central nervous system
- •neurological or psychiatric diseases
- •contraindications against propofol, sevoflurane, S-ketamine or remifentanil
- •any damages or loss of hearing
- •heartburn or any stomach diseases
研究组 & 干预措施
1
remifentanil
干预措施: Remifentanil (Drug)
2
propofol
干预措施: Propofol (Drug)
3
sevoflurane
干预措施: Sevoflurane (Drug)
4
s-ketamine
干预措施: S-Ketamine (Drug)
结局指标
主要结局
influence of different drugs on evoked responses
时间窗: 2 hours
次要结局
- discrimination of antinociceptive, visceral-perceptive and sedative effects of anesthetics(2 hours)
- quantification of anesthetic components of propofol, sevoflurane, S-ketamine and remifentanil(2 hours)