Occupational ExposureNCT03891316
Sevoflurane Human Biomonitoring in Operating Room Personnel
An observational study of Occupational Exposure, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Occupational Exposure
- What is being tested?
- HFIP and Sevoflurane are measured after 3 consecutive days of work.
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 11 Mar 2019to 22 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Physicans with or without occupational exposure to sevoflurane.
Who may be able to join
- 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)
Who cannot join
- Presence during a mask induction with sevoflurane
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Occupational Exposure
- Being tested
- HFIP and Sevoflurane are measured after 3 consecutive days of work.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Anaesthesiologists balanced | Anaesthesiologists performing balanced anaesthesia with sevoflurane. Receives: Diagnostic Test: HFIP and Sevoflurane are measured after 3 consecutive days of work. | |
| Anaesthesiologists TIVA | Anaesthesiologists performing only total intravenous anaesthesia. Receives: 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. Receives: Diagnostic Test: HFIP and Sevoflurane are measured after 3 consecutive days of work. | |
| Anaesthesiologists PACU | Anaesthesiologists working in the postoperative care unit. Receives: 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 Receives: 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 Receives: Diagnostic Test: HFIP and Sevoflurane are measured after 3 consecutive days of work. | |
| Patients | Patients having undergone sevoflurane anesthesia for elective surgery Receives: Diagnostic Test: HFIP and Sevoflurane are measured after 3 consecutive days of work. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary HFIP concentration (µg/l)
After 3 consecutive days of work a urine sample is collected and urinary HFIP is measured by gas chromatography
Measured: 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
Measured: After 3 consecutive days of work
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start11 Mar 2019
- Primary completion22 Mar 2021
- Study completion22 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational ExposureStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katharina Roeher, Dr. med, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891316
- Sponsor's protocol ID
- PV5820
- Status last verified
- May 2021
- First submitted
- 10 Mar 2019
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Biomonitoring of Operating Room Personnel With Occupational Exposure to the Volatile Anaesthetic Sevoflurane
- ClinicalTrials.gov ID
- NCT03891316
- Acronym / sponsor ID
- PV5820
- Conditions
- Occupational Exposure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 22 Mar 2021 (actual)
- Study completion
- 22 Mar 2021 (actual)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Anaesthesiologists balanced | – | Diagnostic Test: HFIP and Sevoflurane are measured after 3 consecutive days of work.Anaesthesiologists performing balanced anaesthesia with sevoflurane. |
| Anaesthesiologists TIVA | – | Diagnostic Test: HFIP and Sevoflurane are measured after 3 consecutive days of work.Anaesthesiologists performing only total intravenous anaesthesia. |
| Surgeons | – | Diagnostic Test: 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 PACU | – | Diagnostic Test: HFIP and Sevoflurane are measured after 3 consecutive days of work.Anaesthesiologists working in the postoperative care unit. |
| Anaesthesiologists outside the operating room | – | Diagnostic Test: 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 |
| Physicians not exposed | – | Diagnostic Test: 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 |
| Patients | – | Diagnostic Test: HFIP and Sevoflurane are measured after 3 consecutive days of work.Patients having undergone sevoflurane anesthesia for elective surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Physicans with or without occupational exposure to sevoflurane.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- Presence during a mask induction with sevoflurane
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HFIP and Sevoflurane are measured after 3 consecutive days of work.Concentration of hexafluoroisopropanol and Sevoflurane are measured in urine by gas chromatography | Diagnostic test | Anaesthesiologists PACU, Anaesthesiologists TIVA, Anaesthesiologists balanced, Anaesthesiologists outside the operating room, Patients, Physicians not exposed, Surgeons |
Primary outcome
Urinary HFIP concentration (µg/l)
Time frame: 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
Urinary sevoflurane concentration (µg/l)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katharina Roeher, Dr. med principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Occupational Exposure, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary HFIP concentration (µg/l) (time frame: After 3 consecutive days of work). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.