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Unrecognized ConditionNCT06487169

Effectivity Gas Extraction to Prevent Anesthesiologists Waste Gas Exposure of Sevofluorane During Pediatric Induction

An observational study of Unrecognized Condition, run by Bnai Zion Medical Center.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Inhalational anesthetics (IAs) are widely used in surgery and experimental research. IAs, in addition to their medical significance, are a major source of chemical contamination in the operating rooms (ORs).Exposure to IAs in ORs personnel results in reproductive effects, including infertility , spontaneous abortions… Read more about this study

Who is it for?
Any age
Conditions the study is for
Unrecognized Condition
What is being tested?
Urine analysis to determine the presence of hexafluoroisopropanol
How many people
10 participants
Where
No sites listed yet
Study dates
1 Aug 2024to 31 Jan 2025
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Ten anesthesiologists that work in Pediatric Induction Room using anesthesia induction with sevoflurane delivery with mask

Inclusion Criteria: anesthesiologists that work in pediatric anesthesia room performed induction anesthesia with sevoflurane delivery by mask -

Exclusion Criteria: anesthesia that required IV induction and that not use sevoflurane

-

About this study

Official title: Effectivity of the Air Extraction to Prevent Anesthesiologists Waste Anesthetic Gas Exposure of Sevoflurane During Pediatric Induction

Inhalational anesthetics (IAs) are widely used in surgery and experimental research. IAs, in addition to their medical significance, are a major source of chemical contamination in the operating rooms (ORs).Exposure to IAs in ORs personnel results in reproductive effects, including infertility , spontaneous abortions , congenital diseases , psychological and neurological disturbances, hepatotoxicity , and genotoxicity .The metabolites of sevoflurane include hexafluoroisopropanol (HFIP) and inorganic fluoride (IF). The hospital's engineering department installed an air extractor with the objective to reduce the anesthetic gas concentrations during pediatric anesthesia induction. The investigators are interested in checking if the new technique also has an influence in decreasing the level of Sevoflurane breathed in by the anesthesiologist.The investigators purpose is to detect the presence of desfluoroisopropanolol in the urine of ten anesthesiologists who used sevoflurane to induce children with a mask during an eight-hour session in the induction room (IR) One session will be conducted without the use of the air extractor and the other with the air extractor. After 24 hours, a urine sample will be taken and sent to the Toxicology Unit.

Read the detailed description

IAs are widely used in surgery. IAs, in addition to their medical significance, are a major source of chemical contamination in the ORs, dental clinics, delivery rooms, and intensive care units Although ORs are equipped with ventilation and scavenging systems, it should be noted that occupational exposure to IAs is still higher than threshold limit value recommended by Occupational Safety and Health Administration (OSHA) .

Exposure to IAs in ORs personnel results in 1. reproductive effects, including 2. infertility 3., spontaneous abortions 4., congenital diseases 5., psychological and neurological disturbances 6., hepatotoxicity 7., and genotoxicity 8.

Possible mechanisms underlying the genotoxic effects of these agents are not clear. It seems that oxidative stress through excessive production of reactive oxygen species (ROS), including superoxide, hydroxyl, and hydrogen peroxide is an important mechanism by which ionizing radiation and IAs cause DNA damage 8.

Urinary HFIP has been recently suggested as a valuable biomarker for the monitoring of occupational exposure of medical staff exposed to low concentration of airborne sevoflurane in operating rooms Minimizing the impact of anesthetic gases contributes to the protection of individuals who experience chronic risk of occupational exposure from waste gases in working environments with poor or inadequate scavenging of inhaled anesthetics.

To ensure occupational safety around IAs in 1977, the US National Institute for Occupational Safety and Health (NIOSH) recommended that occupational exposure to halogenated anesthetics agents should not exceed 2 ppm or N2O >25 ppm within a 1-hour period (reweighted average for exposure duration) To manage and minimize occupational exposure to WAGs, NIOSH and others highlight the pivotal importance of using an efficient air ventilation Anesthesia induction specially a performed with needle injection is a stressful part of surgery for pediatric patients and their parents. Children may undergo physical, mental, and physiological distress due to anxiety at the time of induction and after surgery, and higher parental anxiety levels are directly associated with children's preoperative anxiety levels .

The parental presence during the use of facial mask to performed the induction with IAs contribute significantly to reduce the anxiety in the children's.

In the Anesthesiology Department of the Bnai Zion Medical Center, the induction technique is performed with sevofluorane and Nitrous Oxide gas loaded through a mask and with parenteral presence.

This anesthetic approach demands to use the mask to perform the induction, therefore, it is not adapted closely to the face of the patient during the short period of time when the child is in the excitatory face. During this time, part of the fresh gas supply leaks to the air of the Pediatric Induction Room (PIR). This technique obviously increases the concentration of sevoflurane and Nitrous Oxide( N2O) over the safety recommended standards range.

In 2022 measurements in a PIR revealed sevoflurane concentrations far above safety standards of 1 to 2 ppm reaching as high as 33.4 ppm. and measurements of N2O concentrations exceeding safety standards of 25 ppm, reaching values as high as 125 ppm .

Since the PIR is not equipped with an air extraction system, the hospital's engineering department installed an air extractor with the objective to reduce the anesthetic gas concentrations during pediatric anesthesia induction.

The investigators checked the levels of sevoflurane in the air of the induction room without the removal of air with sevoflurane and with the removal of air contaminated with sevoflurane.

The average sevoflurane concentration recorded without use of the air extractor was (Mean = 10.86, SD = 8.67) significantly exceeded the mean concentration of sevoflurane observed subsequent to the extractor application (Mean = 0.18, SD = 0.31) Stimulated by the results obtained in the PIR air, we are interested in checking if the new technique also has an influence in decreasing the level of Sevoflurane breathed in by the anesthesiologist.

HFIP is a major metabolite of sevoflurane and is excreted in the urine within the first few hours after exposure.

The Laboratory of Clinical Toxicology, Pharmacology and Pharmacogenetic of the Rambam Health Care Campus has the capability to identifying and quantifying the HFIP in urine using the technique of Mass Spectrometry.

The investigators purpose is to detect the presence of HFIP in the urine of ten anesthesiologists who used sevoflurane to induce children with a mask during an eight-hour session in the PIR. One session will be conducted without the use of the air extractor and the other with the air extractor. After 24 hours, a urine sample will be taken and sent to the Toxicology Unit.

Being tested
Urine analysis to determine the presence of hexafluoroisopropanol
Keywords
sevofluorane,, hexacloroisopropanolol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Urine analysis to determine the presence of hexafluoroisopropanolDiagnostic test

    analysis of sevoflurane metabolites in urine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Presence of sevoflurane metabolite, hexafluoroisopropanol in urine

    hexafluoroisopropanol is the metabolism of the sevofluorane

    Measured: up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2024
  2. Study start1 Aug 2024 (estimated)
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Jan 2025 (estimated)

Resources

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
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06487169
Sponsor's protocol ID
0072-24-BNZ
Status last verified
Jul 2024
First submitted
24 Jun 2024
Last updated
5 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Somri F, Hossein J, Somri M, Hochman O, Gaitini L, Efrati E, Gomez-Rios MA. Reduction of Anesthesiologists' Sevoflurane Exposure During Pediatric Mask Induction With an Additional Scavenger: A Randomized Study. Paediatr Anaesth. 2026 Aug;36(8):957-963. doi: 10.1002/pan.70205. Epub 2026 May 6.

    PubMed 42087837

Questions about this trial

What is this clinical trial studying?

An observational study of Unrecognized Condition, run by Bnai Zion Medical Center.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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?

Presence of sevoflurane metabolite, hexafluoroisopropanol in urine (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06487169, which also lists 1 linked publication.

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 5 Jul 2024.

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