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.
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.
- Conditions
- Unrecognized Condition
- 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.
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.
- First posted5 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unrecognized ConditionStudies of the same condition, open and under way.
- 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, MOSTAFA.SOMRI, Bnai Zion Medical Center
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectivity of the Air Extraction to Prevent Anesthesiologists Waste Anesthetic Gas Exposure of Sevoflurane During Pediatric Induction
- ClinicalTrials.gov ID
- NCT06487169
- Acronym / sponsor ID
- 0072-24-BNZ
- Conditions
- Unrecognized Condition
- Keywords
- sevofluorane,, hexacloroisopropanolol
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 5 Jul 2024 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Ten anesthesiologists that work in Pediatric Induction Room using anesthesia induction with sevoflurane delivery with mask
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 |
|---|---|---|
| Urine analysis to determine the presence of hexafluoroisopropanolanalysis of sevoflurane metabolites in urine | Diagnostic test | – |
Primary outcome
Presence of sevoflurane metabolite, hexafluoroisopropanol in urine
Time frame: up to 24 weeks
hexafluoroisopropanol is the metabolism of the sevofluorane
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Derived from this study: PubMed 42087837Somri 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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.