Sevoflurane Human Biomonitoring in Operating Room Personnel

Universitätsklinikum Hamburg-Eppendorf

Status: Completed

Conditions: Occupational Exposure

Treatments: Diagnostic Test: HFIP and Sevoflurane are measured after 3 consecutive days of work.

Study type: Observational

Funder types: Other

Identifiers

NCT03891316

PV5820

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

40 participants in 7 patient groups

Anaesthesiologists balanced

Description:

Anaesthesiologists performing balanced anaesthesia with sevoflurane.

Treatment:

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

Anaesthesiologists TIVA

Description:

Anaesthesiologists performing only total intravenous anaesthesia.

Treatment:

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

Surgeons

Description:

Surgeons working in the operating room while anaesthesia of the patients is randomly maintained with sevoflurane or propofol.

Treatment:

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

Anaesthesiologists PACU

Description:

Anaesthesiologists working in the postoperative care unit.

Treatment:

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

Anaesthesiologists outside the operating room

Description:

Anaesthesiologists working outside of the operating room, for example pain service or anaesthesiological walk-in clinic

Treatment:

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

Physicians not exposed

Description:

Physicians not having contact with patients on wards/outpatient clinics after exposure with sevoflurane

Treatment:

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

Patients

Description:

Patients having undergone sevoflurane anesthesia for elective surgery

Treatment:

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