Sevoflurane Human Biomonitoring in Operating Room Personnel

NCT03891316 | Completed

• 1 other identifier: PV5820
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Occupational Exposure

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (7)

Anaesthesiologists balanced

Anaesthesiologists performing balanced anaesthesia with sevoflurane.

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

Anaesthesiologists TIVA

Anaesthesiologists performing only total intravenous anaesthesia.

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

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.

Anaesthesiologists PACU

Anaesthesiologists working in the postoperative care unit.

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

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.

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.

Patients

Patients having undergone sevoflurane anesthesia for elective surgery

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

Interventions

HFIP and Sevoflurane are measured after 3 consecutive days of work. DIAGNOSTIC_TEST

Concentration of hexafluoroisopropanol and Sevoflurane are measured in urine by gas chromatography

Anaesthesiologists PACU; Anaesthesiologists TIVA; Anaesthesiologists balanced; Anaesthesiologists outside the operating room; Patients; Physicians not exposed; Surgeons

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Physicans with or without occupational exposure to sevoflurane.

You may qualify if:

• 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)

You may not qualify if:

• Presence during a mask induction with sevoflurane

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urinary Samples

Study Officials

• Katharina Roeher, Dr. med

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2019
• First Posted: March 27, 2019
• Study Start: March 11, 2019
• Primary Completion: March 22, 2021
• Study Completion: March 22, 2021
• Last Updated: May 18, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)