Clinical Trials Directory

Trials / Completed

CompletedNCT03891316

Sevoflurane Human Biomonitoring in Operating Room Personnel

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

Status
Completed
Phase
Study type
Observational
Enrollment
40 (actual)
Sponsor
Universitätsklinikum Hamburg-Eppendorf · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTHFIP and Sevoflurane are measured after 3 consecutive days of work.Concentration of hexafluoroisopropanol and Sevoflurane are measured in urine by gas chromatography

Timeline

Start date
2019-03-11
Primary completion
2021-03-22
Completion
2021-03-22
First posted
2019-03-27
Last updated
2021-05-18

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT03891316. Inclusion in this directory is not an endorsement.