Sevoflurane Human Biomonitoring in Operating Room Personnel

Completed

• Conditions: Occupational Exposure
• Interventions: Diagnostic Test: HFIP and Sevoflurane are measured after 3 consecutive days of work.

• Registration Number: NCT03891316
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Study Timeline

• Study First Submitted: 2019-03-10
• Study Start: 2019-03-11
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-27
• Primary Completion: 2021-03-22
• Study Completion: 2021-03-22
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-15
• Last Update Posted: 2021-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anaesthesiologists balanced	HFIP and Sevoflurane are measured after 3 consecutive days of work.	Anaesthesiologists performing balanced anaesthesia with sevoflurane.
Anaesthesiologists PACU	HFIP and Sevoflurane are measured after 3 consecutive days of work.	Anaesthesiologists working in the postoperative care unit.
Patients	HFIP and Sevoflurane are measured after 3 consecutive days of work.	Patients having undergone sevoflurane anesthesia for elective surgery
Physicians not exposed	HFIP and Sevoflurane are measured after 3 consecutive days of work.	Physicians not having contact with patients on wards/outpatient clinics after exposure with sevoflurane
Surgeons	HFIP and Sevoflurane are measured after 3 consecutive days of work.	Surgeons working in the operating room while anaesthesia of the patients is randomly maintained with sevoflurane or propofol.
Anaesthesiologists TIVA	HFIP and Sevoflurane are measured after 3 consecutive days of work.	Anaesthesiologists performing only total intravenous anaesthesia.
Anaesthesiologists outside the operating room	HFIP and Sevoflurane are measured after 3 consecutive days of work.	Anaesthesiologists working outside of the operating room, for example pain service or anaesthesiological walk-in clinic

Primary Outcome Measures

Name	Time	Method
Urinary sevoflurane concentration (µg/l)	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
Urinary HFIP concentration (µg/l)	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

Trial Locations

Locations (1)

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany