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Intraoperative Different Concentrations Oxygen And Oxidatıve Stress Markers

Primary Purpose

Stress, Hyperoxia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
taking arterial blood sample through the injector
Sponsored by
Zonguldak Bulent Ecevit University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stress focused on measuring oxidative stress markers, general anesthesia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Zonguldak Bülent Ecevit University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

group I

group II

Arm Description

50%Fio2

30%Fio2

Outcomes

Primary Outcome Measures

EFFECTS OF INTRAOPERATIVE OXYGEN USED AT DIFFERENT CONCENTRATIONS ON OXIDATIVE STRESS MARKERS
TAS and TOS values occurring at different oxygen concentrations

Secondary Outcome Measures

Full Information

First Posted
September 8, 2021
Last Updated
October 18, 2021
Sponsor
Zonguldak Bulent Ecevit University
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1. Study Identification

Unique Protocol Identification Number
NCT05099523
Brief Title
Intraoperative Different Concentrations Oxygen And Oxidatıve Stress Markers
Official Title
The Effects of Intraoperative Oxygen Used at Different Concentrations on Oxidatıve Stress Markers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
May 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zonguldak Bulent Ecevit University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Hyperoxia
Keywords
oxidative stress markers, general anesthesia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group I
Arm Type
Placebo Comparator
Arm Description
50%Fio2
Arm Title
group II
Arm Type
Active Comparator
Arm Description
30%Fio2
Intervention Type
Procedure
Intervention Name(s)
taking arterial blood sample through the injector
Intervention Description
taking blood samples from patients applied with different oxygen concentrations
Primary Outcome Measure Information:
Title
EFFECTS OF INTRAOPERATIVE OXYGEN USED AT DIFFERENT CONCENTRATIONS ON OXIDATIVE STRESS MARKERS
Description
TAS and TOS values occurring at different oxygen concentrations
Time Frame
end of the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Zonguldak Bülent Ecevit University
City
Zonguldak
State/Province
Kozlu
ZIP/Postal Code
67600
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Intraoperative Different Concentrations Oxygen And Oxidatıve Stress Markers

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