Oxidative Stress in OR Personnel

January 23, 2018 updated by: Haleh Saadat, Nationwide Children's Hospital

Oxidative Stress Status During Anesthesia in Pediatric Surgical Room Staff Versus Non-operating Room Personnel: Pilot Study

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Twenty operating room staff and twenty intensive care unit staff (40 Total Participants)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pediatric Operating Room (OR) Staff
OR Staff exposed to nitrous oxide, and other volatile anesthetics
Other: Exposure to nitrous oxide or other volatile anesthetics
No intervention, but routine work-place exposure to volatile anesthetics
Pediatric Intensive Care Unit (ICU) Staff
ICU Staff unexposed to any volatile anesthetics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxidative Stress
Time Frame: During exposure to volatile anesthetics over the course of a week in the work-place
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.
During exposure to volatile anesthetics over the course of a week in the work-place

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological Stress
Time Frame: During exposure to volatile anesthetics over the course of a week in the work-place
To determine the relationship between oxidative stress and psychological stress, as assessed by validated psychometric measures.
During exposure to volatile anesthetics over the course of a week in the work-place

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nationwide Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

January 11, 2016

First Submitted That Met QC Criteria

January 11, 2016

First Posted (Estimate)

January 13, 2016

Study Record Updates

Last Update Posted (Actual)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB14-00098

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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