Oxidative Stress in OR Personnel

Oxidative Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02654834
• Other study ID #: IRB14-00098
• Status: Withdrawn
• Phase: N/A
• First received: January 11, 2016
• Last updated: January 23, 2018
• Start date: May 2014
• Est. completion date: March 2016

Study information

• Verified date: January 2018
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Oxidative Stress

Intervention

Other:
• Exposure to nitrous oxide or other volatile anesthetics
No intervention, but routine work-place exposure to volatile anesthetics

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxidative Stress	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	Psychological Stress	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