Sevoflurane Human Biomonitoring in Operating Room Personnel

NCT ID: NCT03891316

Last Updated: 2021-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-11

Study Completion Date

2021-03-22

Brief Summary

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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

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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.

Conditions

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Occupational Exposure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Anaesthesiologists balanced

Anaesthesiologists performing balanced anaesthesia with sevoflurane.

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

Intervention Type DIAGNOSTIC_TEST

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

Anaesthesiologists TIVA

Anaesthesiologists performing only total intravenous anaesthesia.

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

Intervention Type DIAGNOSTIC_TEST

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.

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

Intervention Type DIAGNOSTIC_TEST

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

Anaesthesiologists PACU

Anaesthesiologists working in the postoperative care unit.

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

Intervention Type DIAGNOSTIC_TEST

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

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

Intervention Type DIAGNOSTIC_TEST

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

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

Intervention Type DIAGNOSTIC_TEST

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

Patients

Patients having undergone sevoflurane anesthesia for elective surgery

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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katharina Roeher, Dr. med

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

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Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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PV5820

Identifier Type: -

Identifier Source: org_study_id

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