Sevoflurane Human Biomonitoring in Operating Room Personnel

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.

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Key information

Conditions

Occupational Exposure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)

Exclusion criteria

Presence during a mask induction with sevoflurane

Treatment and study plan

HFIP and Sevoflurane are measured after 3 consecutive days of work.

Diagnostic Test

Concentration of hexafluoroisopropanol and Sevoflurane are measured in urine by gas chromatography

Primary outcomes

Urinary HFIP concentration (µg/l)

Time frame: 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
Urinary sevoflurane concentration (µg/l)

Time frame: 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

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

Human Biomonitoring of Operating Room Personnel With Occupational Exposure to the Volatile Anaesthetic Sevoflurane

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Mar 27, 2019
Registry last updated: May 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed