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临床试验/NCT00321191
NCT00321191已完成4 期

Measurement of the Second Gas Effect on Sevoflurane in Anaesthetised Patients

Austin Health1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2006年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
Austin Health
入组人数
14
试验地点
1
主要终点
Fa/FI sevoflurane in 100% O2 vs in 70% N2O and 30% O2 during 1st 60 min anaesthesia

研究概览

简要总结

This study is investigating the "second gas effect", a phenomenon produced by the uptake of nitrous oxide (N2O) by the lungs, during the course of a typical anaesthetic. The effect is to increase the concentration of other breathed gases in the lung. These include oxygen and volatile anaesthetic agents such as sevoflurane, which are also normally administered along with N2O. We wish to i) measure the magnitude of the second gas effects on both blood and expired concentrations of sevoflurane (Part 1), and ii) see if a demonstrable difference exists between the effects on blood and expired concentrations.

详细描述

This study is investigating the "second gas effect", a phenomenon produced by the uptake of nitrous oxide (N2O) by the lungs, during the course of a typical anaesthetic. The effect is to increase the concentration of other breathed gases in the lung. These include oxygen and volatile anaesthetic agents such as sevoflurane, which are also normally administered along with N2O.

While the second gas effect has been demonstrated previously, by measuring the concentration of volatile anaesthetic in the expired breath, no study has yet shown that it has a significant effect on the concentrations in the blood. The blood concentration is in fact more important, as it directly determines the concentration of anaesthetic reaching the brain, and therefore the effect on the depth of anaesthesia. The second gas effect on blood concentrations may be more powerful than that on expired concentrations, due to the detrimental effect of anaesthesia on the evenness of distribution of ventilation and blood flow in the lung.

The proposed study will have two parallel components or Parts. We wish to i) measure the magnitude of the second gas effects on both blood and expired concentrations of sevoflurane (Part 1), and ii) see if a demonstrable difference exists between the effects on blood and expired concentrations.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for elective surgery requiring relaxant general anaesthesia with arterial blood pressure monitoring via an arterial line.
  • Exclusion criteria:
  • Patients with moderately or severely impaired respiratory disease (FEV1 < 1.5L, or FVC < 2.0L).
  • Patients under 18 years of age.
  • Morbidly obese patients: BMI > 30
  • Patients unable to give informed consent.

排除标准

  • 未提供

研究组 & 干预措施

No N2O

Placebo Comparator

干预措施: No nitrous oxide (Drug)

N2O

Experimental

干预措施: Administration of N2O (Drug)

结局指标

主要结局

Fa/FI sevoflurane in 100% O2 vs in 70% N2O and 30% O2 during 1st 60 min anaesthesia

Change in Fa/FI sevoflurane in 100% O2 vs in 70% N2O and 30% O2 after 60 minutes anaesthesia

次要结局

  • Fa/FI and FA/FI for N2O will also be recorded.

研究者

发起方
Austin Health
申办方类型
Other Gov

研究点 (1)

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