NCT06487169

Brief 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 , 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 5, 2024

Completed
27 days until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

July 5, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

June 24, 2024

Last Update Submit

July 2, 2024

Conditions

Keywords

sevofluorane,hexacloroisopropanolol

Outcome Measures

Primary Outcomes (1)

  • Presence of sevoflurane metabolite, hexafluoroisopropanol in urine

    hexafluoroisopropanol is the metabolism of the sevofluorane

    up to 24 weeks

Interventions

analysis of sevoflurane metabolites in urine

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Anesthesiologists

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

June 24, 2024

First Posted

July 5, 2024

Study Start

August 1, 2024

Primary Completion

December 31, 2024

Study Completion

January 31, 2025

Last Updated

July 5, 2024

Record last verified: 2024-07