Oxidative Stress in OR Personnel

NCT ID: NCT02654834

Last Updated: 2018-01-25

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-03-31

Brief Summary

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The purpose of this study is investigate to the effect(s) of chronic occupational exposure to N20 and volatile anesthetics on the extent of oxidative stress (DNA damage and the generation of the biochemical markers) in operating room staff, with different levels of exposure to halogenated hydrocarbons, in comparison to unexposed controls (Intensive Care Staff), and to determine the relationship between the degree of oxidative stress and psychological stress, as assessed by validated psychometric measures.

Detailed Description

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This is a single blinded randomized, controlled and prospective clinical trial comparing oxidative stress status in two groups.

Subjects in two groups will be matched for gender, age, smoking habit and employment duration and will be randomized into one of the two groups of:

1. Pediatric OR Staff, and
2. control (e.g; ICU staff)

Biomarkers of oxidative stress will be measured in two different time points in each subject, (Monday Morning and, Friday afternoon of that same week-\>40 hours in Operating room or Intensive Care Unit).

The relationship between oxidative stress and psychological stress will also be assessed by validated psychometric measures.

Conditions

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Oxidative Stress

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Pediatric Operating Room (OR) Staff

OR Staff exposed to nitrous oxide, and other volatile anesthetics

Exposure to nitrous oxide or other volatile anesthetics

Intervention Type OTHER

No intervention, but routine work-place exposure to volatile anesthetics

Pediatric Intensive Care Unit (ICU) Staff

ICU Staff unexposed to any volatile anesthetics

No interventions assigned to this group

Interventions

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Exposure to nitrous oxide or other volatile anesthetics

No intervention, but routine work-place exposure to volatile anesthetics

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. CHOR-Staff who work \> 40 hours per week in the operating rooms (Anesthesiologists, CRNA, Surgeons, Nurses)
2. NOR- Intensive Care Unit Staff who work \> 40 hours per week in Intensive care unit (Physicians, Nurses, APN'S)

Exclusion Criteria

Staff with the following history will be excluded:

1. Therapeutic exposure to radiation
2. On chemotherapeutic agents
3. History of General Anesthesia during the past two years
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nationwide Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Haleh Saadat

Director of Complementary and Alternative Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Haleh Saadat, MD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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IRB14-00098

Identifier Type: -

Identifier Source: org_study_id

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