Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-04-23 @ 11:16 PM
Study NCT ID:
NCT02654834
Status:
WITHDRAWN
Last Update Posted:
2018-01-25
First Post:
2016-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxidative Stress in OR Personnel
Sponsor:
Nationwide Children's Hospital
Organization:
Study Overview
Official Title:
Oxidative Stress Status During Anesthesia in Pediatric Surgical Room Staff Versus Non-operating Room Personnel: Pilot Study
Status:
WITHDRAWN
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: