Sevoflurane Human Biomonitoring in Operating Room Personnel

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

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.

Study Overview

• Status: Completed
• Conditions: Occupational Exposure
• Intervention / Treatment: Diagnostic test: HFIP and Sevoflurane are measured after 3 consecutive days of work.

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 Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg-Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Physicans with or without occupational exposure to sevoflurane.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

7

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Katharina Roeher, Dr. med, Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 11, 2019
• Primary Completion (ACTUAL): March 22, 2021
• Study Completion (ACTUAL): March 22, 2021

Study Registration Dates

• First Submitted: March 10, 2019
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (ACTUAL): March 27, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 18, 2021
• Last Update Submitted That Met QC Criteria: May 15, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Anesthetics, Inhalation; Sevoflurane
• Other Study ID Numbers: PV5820

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No