NCT05099523

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 29, 2021

Completed
Last Updated

October 29, 2021

Status Verified

October 1, 2021

Enrollment Period

4 months

First QC Date

September 8, 2021

Last Update Submit

October 18, 2021

Conditions

StressHyperoxia

Keywords

oxidative stress markersgeneral anesthesia

Outcome Measures

Primary Outcomes (1)

  • EFFECTS OF INTRAOPERATIVE OXYGEN USED AT DIFFERENT CONCENTRATIONS ON OXIDATIVE STRESS MARKERS

    TAS and TOS values occurring at different oxygen concentrations

    end of the surgery

Study Arms (2)

group I

PLACEBO COMPARATOR

50%Fio2

Procedure: taking arterial blood sample through the injector

group II

ACTIVE COMPARATOR

30%Fio2

Procedure: taking arterial blood sample through the injector

Interventions

taking arterial blood sample through the injectorPROCEDURE

taking blood samples from patients applied with different oxygen concentrations

group Igroup II

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Bülent Ecevit University

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hyperoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 8, 2021

First Posted

October 29, 2021

Study Start

February 1, 2021

Primary Completion

May 30, 2021

Study Completion

May 30, 2021

Last Updated

October 29, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will share

Locations

TU(1)