Skip to content

Sevoflurane Human Biomonitoring in Operating Room Personnel

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03891316
Enrollment
40
Registered
2019-03-27
Start date
2019-03-11
Completion date
2021-03-22
Last updated
2021-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Occupational Exposure

Brief summary

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.

Detailed description

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.

Interventions

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

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

Sponsors

Universitätsklinikum Hamburg-Eppendorf
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Urinary HFIP concentration (µg/l)After 3 consecutive days of workAfter 3 consecutive days of work a urine sample is collected and urinary HFIP is measured by gas chromatography
Urinary sevoflurane concentration (µg/l)After 3 consecutive days of workAfter 3 consecutive days of work a urine sample is collected and urinary sevoflurane is measured by gas chromatography

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026