Oxidative Stress in OR Personnel

Withdrawn

• Conditions: Oxidative Stress
• Interventions: Other: Exposure to nitrous oxide or other volatile anesthetics

• Registration Number: NCT02654834
• Lead Sponsor: Nationwide Children's Hospital

Brief Summary

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

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 Timeline

• Study Start: 2014-05
• Study First Submitted: 2016-01-11
• Study First Submitted QC: 2016-01-11
• Study First Posted: 2016-01-13
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric Operating Room (OR) Staff	Exposure to nitrous oxide or other volatile anesthetics	OR Staff exposed to nitrous oxide, and other volatile anesthetics

Primary Outcome Measures

Name	Time	Method
Oxidative Stress	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.

Secondary Outcome Measures

Name	Time	Method
Psychological Stress	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.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States