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临床试验/NCT06487169
NCT06487169尚未招募不适用

Effectivity of the Air Extraction to Prevent Anesthesiologists Waste Anesthetic Gas Exposure of Sevoflurane During Pediatric Induction

Bnai Zion Medical Center0 个研究点目标入组 10 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
10
主要终点
Presence of sevoflurane metabolite, hexafluoroisopropanol in urine

研究概览

简要总结

Inhalational anesthetics (IAs) are widely used in surgery and experimental research. IAs, in addition to their medical significance, are a major source of chemical contamination in the operating rooms (ORs).Exposure to IAs in ORs personnel results in reproductive effects, including infertility , spontaneous abortions , congenital diseases , psychological and neurological disturbances, hepatotoxicity , and genotoxicity .The metabolites of sevoflurane include hexafluoroisopropanol (HFIP) and inorganic fluoride (IF). The hospital's engineering department installed an air extractor with the objective to reduce the anesthetic gas concentrations during pediatric anesthesia induction. The investigators are interested in checking if the new technique also has an influence in decreasing the level of Sevoflurane breathed in by the anesthesiologist.The investigators purpose is to detect the presence of desfluoroisopropanolol in the urine of ten anesthesiologists who used sevoflurane to induce children with a mask during an eight-hour session in the induction room (IR) One session will be conducted without the use of the air extractor and the other with the air extractor. After 24 hours, a urine sample will be taken and sent to the Toxicology Unit.

详细描述

IAs are widely used in surgery. IAs, in addition to their medical significance, are a major source of chemical contamination in the ORs, dental clinics, delivery rooms, and intensive care units Although ORs are equipped with ventilation and scavenging systems, it should be noted that occupational exposure to IAs is still higher than threshold limit value recommended by Occupational Safety and Health Administration (OSHA) .

Exposure to IAs in ORs personnel results in 1. reproductive effects, including 2. infertility 3., spontaneous abortions 4., congenital diseases 5., psychological and neurological disturbances 6., hepatotoxicity 7., and genotoxicity 8.

Possible mechanisms underlying the genotoxic effects of these agents are not clear. It seems that oxidative stress through excessive production of reactive oxygen species (ROS), including superoxide, hydroxyl, and hydrogen peroxide is an important mechanism by which ionizing radiation and IAs cause DNA damage 8.

Urinary HFIP has been recently suggested as a valuable biomarker for the monitoring of occupational exposure of medical staff exposed to low concentration of airborne sevoflurane in operating rooms Minimizing the impact of anesthetic gases contributes to the protection of individuals who experience chronic risk of occupational exposure from waste gases in working environments with poor or inadequate scavenging of inhaled anesthetics.

To ensure occupational safety around IAs in 1977, the US National Institute for Occupational Safety and Health (NIOSH) recommended that occupational exposure to halogenated anesthetics agents should not exceed 2 ppm or N2O >25 ppm within a 1-hour period (reweighted average for exposure duration) To manage and minimize occupational exposure to WAGs, NIOSH and others highlight the pivotal importance of using an efficient air ventilation Anesthesia induction specially a performed with needle injection is a stressful part of surgery for pediatric patients and their parents. Children may undergo physical, mental, and physiological distress due to anxiety at the time of induction and after surgery, and higher parental anxiety levels are directly associated with children's preoperative anxiety levels .

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • anesthesiologists that work in pediatric anesthesia room performed induction anesthesia with sevoflurane delivery by mask -

排除标准

  • anesthesia that required IV induction and that not use sevoflurane

结局指标

主要结局

Presence of sevoflurane metabolite, hexafluoroisopropanol in urine

时间窗: up to 24 weeks

hexafluoroisopropanol is the metabolism of the sevofluorane

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

MOSTAFA.SOMRI

Clinical Associate Professor

Bnai Zion Medical Center

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