Completed

Comparing the Effect of Hyperoxic and Conventional Fraction of Inspired Oxygen on Oxidative Stress During Abdominal Surgery.

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What is being tested

Fraction of inspired oxygen 40%

+ Fraction of inspired oxygen 80%

Other
Who is being recruted

From 20 to 60 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorIstanbul University
Last updated: April 9, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

Our aim is to compare the effects of 80% and 40% Fraction of inspired oxygen on oxidative stress, antioxidant response (in plasma and bronchoalveolar lavage), extubation quality, preanesthetic and postanesthetic expiration tidal volumes.

NCT01793454
Principal SponsorIstanbul University
Last updated: April 9, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria: Patients undergoing abdominal surgery, between 20-60 years old, with American Society of Anesthesiology score I or II Exclusion Criteria: Patients with Chronic Obstructive Pulmonary Disease, Diabetes Mellitus, muscle-bone diseases, inflammatory bowel diseases and patients with malnutrition. Patients will be recruited through general surgery service of our hospital

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Patients in this group will be ventilated with fraction of inspired oxygen 40% during the surgery.

Group II

Active Comparator
Patients in this group will be ventilated with a fraction of inspired oxygen 80% during the surgery.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Cerrahpasa Medical Faculty Anesthesiology and Reanimation Department

Istanbul, Turkey (Türkiye)Open Cerrahpasa Medical Faculty Anesthesiology and Reanimation Department in Google Maps
CompletedOne Study Center