Intraoperative Different Concentrations Oxygen And Oxidatıve Stress Markers

October 18, 2021 updated by: Gamze Küçükosman, Zonguldak Bulent Ecevit University

The Effects of Intraoperative Oxygen Used at Different Concentrations on Oxidatıve Stress Markers

The aim of the study was to assess the effect of intraoperative oxygen (O2), which was applied at 30% and 50% concentrations on patients who had undergone septoplasty surgery, on Total Oxidant Status (TOS), Total Antioxidant Status (TAS), and Oxidative Stress Index (OSI).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

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

  • Turkey
    • Kozlu
      • Zonguldak, Kozlu, Turkey, 67600
        • Zonguldak Bülent Ecevit University

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients aged between 18-60 years,
  • ASA I-II risk class with a minimum operative time of 1.5 hour(s) for whom septoplasty operation under elective conditions

Exclusion Criteria:

  • metabolic, endocrine, hepatic, cardiac, or renal diseases,
  • malignancies and who used a drug with antioxidant properties such as vitamin E-C
  • acetylcysteine in the last 48 hours,
  • patients requiring intraoperative 100% O2 inhalation

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: group I
50%Fio2
Procedure: taking arterial blood sample through the injector
taking blood samples from patients applied with different oxygen concentrations
Active Comparator: group II
30%Fio2
Procedure: taking arterial blood sample through the injector
taking blood samples from patients applied with different oxygen concentrations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EFFECTS OF INTRAOPERATIVE OXYGEN USED AT DIFFERENT CONCENTRATIONS ON OXIDATIVE STRESS MARKERS
Time Frame: end of the surgery
TAS and TOS values occurring at different oxygen concentrations
end of the surgery

Collaborators and Investigators

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

Sponsor

Zonguldak Bulent Ecevit University

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 (Actual)

February 1, 2021

Primary Completion (Actual)

May 30, 2021

Study Completion (Actual)

May 30, 2021

Study Registration Dates

First Submitted

September 8, 2021

First Submitted That Met QC Criteria

October 18, 2021

First Posted (Actual)

October 29, 2021

Study Record Updates

Last Update Posted (Actual)

October 29, 2021

Last Update Submitted That Met QC Criteria

October 18, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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