Sevoflurane Human Biomonitoring in Operating Room Personnel

Occupational Exposure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03891316
• Other study ID #: PV5820
• Status: Completed
• Start date: March 11, 2019
• Est. completion date: March 22, 2021

Study information

• Verified date: May 2021
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 22, 2021
• Est. primary completion date: March 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Occupational Exposure

Intervention

Diagnostic Test:
• HFIP and Sevoflurane are measured after 3 consecutive days of work.
Concentration of hexafluoroisopropanol and Sevoflurane are measured in urine by gas chromatography

Locations

Country	Name	City	State
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary HFIP concentration (µg/l)	After 3 consecutive days of work a urine sample is collected and urinary HFIP is measured by gas chromatography	After 3 consecutive days of work
Primary	Urinary sevoflurane concentration (µg/l)	After 3 consecutive days of work a urine sample is collected and urinary sevoflurane is measured by gas chromatography	After 3 consecutive days of work