Human Biomonitoring of Operating Room Personnel With Occupational Exposure to the Volatile Anaesthetic Sevoflurane
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Urinary sevoflurane concentration (µg/l)
研究概览
简要总结
Sevoflurane is a widely used volatile agent for induction and maintenance of anaesthesia. The administration of sevoflurane involves the risk of occupational exposure. Possible negative implications of chronic occupational exposure to sevoflurane are not completely refuted. In Germany no maximum workplace concentration for sevoflurane is defined. This study aims to find out if working conditions of physicians and different anaesthesia techniques effect the extent of occupational exposure to sevoflurane.
详细描述
In this prospective observational trial 7 cohorts of 4 participants each are investigated. The cohorts consist of physicians working at different places in the operating theatre with different occupational exposure to sevoflurane, and one cohort not working in the operating theatre at all. In order to determine the extent of occupational exposure to sevoflurane a human biomonitoring is conducted. Urinary Sevoflurane and its metabolite hexafluoroisopropanol (HFIP) are measured after 3 consecutive working days.
UPDATE: After detecting traces of HFIP in all cohorts even in physicians not working in the operating theatre measurements were repeated, more cohorts were added including a negative control and measurements before the study period of 3 consecutive working days were added.
UPDATE: For comparison one cohort of patients having undergone sevoflurane anaesthesia was added.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Occupational exposure to sevoflurane while conducting sevoflurane anaesthesia/being present during sevoflurane anaesthesia
- •Possible occupational exposure to sevoflurane while working in the operating room/perioperative anaesthesia care unit
- •No occupational exposure to sevoflurane (working outside the operating theatre)
排除标准
- •Presence during a mask induction with sevoflurane
结局指标
主要结局
Urinary sevoflurane concentration (µg/l)
时间窗: After 3 consecutive days of work
After 3 consecutive days of work a urine sample is collected and urinary sevoflurane is measured by gas chromatography
Urinary HFIP concentration (µg/l)
时间窗: After 3 consecutive days of work
After 3 consecutive days of work a urine sample is collected and urinary HFIP is measured by gas chromatography
次要结局
未报告次要终点