Addition of Nitrous Oxide to a Sevoflurane or Propofol Based Anesthetic and Its Effects on Depth of Anesthesia Indices (N20)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- The Effect of Nitrous Oxide on Bispectral Index (BIS) and State Entropy Index (SE)
研究概览
简要总结
The study hypothesizes that adding 60% nitrous oxide to a steady state sevoflurance or propofol anesthetic will lead to a decrease in both BIS and Entropy indices during a constant level of surgical stimulus
详细描述
Nitrous oxide is a widely used general anesthetic pas. It is often used in addition to a second, more potent agent. BIS and Entropy are depth of anesthesia monitors in clinical use. There are conflicting reports about the usefulness of these monitors when nitrous oxide is used as a part of the anesthetic regimen. While some studies demonstrate a decrease in BIS and Entropy, this study aims to investigate the effects of adding nitrous oxide to a sevoflurane or a propofol based anesthetic on BIS and Entropy indices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18 to 55yrs
- •ASA status less than and equal to 2
排除标准
- •Surgery on head and neck
- •ASA greater than 3
- •Contraindication to nitrous oxide
- •Pregnant women
- •History of dementia and stroke, or other organic brain disorder
- •Ear surgery
研究组 & 干预措施
Sevoflurane group
Sevoflurane based general anesthesia
干预措施: Sevoflurane group (Drug)
Propofol group
Propofol based general anesthesia
干预措施: Propofol group (Drug)
结局指标
主要结局
The Effect of Nitrous Oxide on Bispectral Index (BIS) and State Entropy Index (SE)
时间窗: From baseline to 20 minutes after the addition of 60% nitrous oxide
We planned this study to compare the effect of adding N2O on BIS and SE during an intravenous or an inhalation anesthetic. We hypothesized that neither BIS nor SE would decrease in response to the addition of N2O to a Propofol anesthetic. We also hypothesized that neither BIS nor SE would decrease in participants under Sevoflurane anesthesia if the inspired concentration of Sevoflurane were carefully and continuously adjusted to maintain a constant end-tidal concentration during the addition and discontinuation of N2O. BIS (0-100) and SE (0-92) are unitless, ordinal indices of anesthetic depth. Both indices are decreased when the depth of anesthesia is increased.
次要结局
未报告次要终点