Oxidative Stress Related to 2 Different Oxygen Concentrations During General Anesthesia. Clinical Trial.

Study Overview
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Brief Summary
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Clinical trial controlled randomized of parallels groups. The study is designed to look for differences in the oxidative stress level among healthy patients receiving 2 different oxygen concentrations: 30% and 60% during general anesthesia. Once the patient has been informed, the affirmative agreement has been obtained and inclusion and exclusion criteria verified the patients are randomized to 30% or 60% oxygen concentration. In the operating room while placing the intravenous line, a sample blood is obtained. General anesthesia is induced and maintained with sevoflurane. After Anesthesia induction the anesthesia machine is fixed in order to provide the oxygen concentration according to the randomization. One hour later a second venous sample is obtained. Samples are stored in cold conditions until their analysis in the laboratories of the biology faculty - Barcelona University.

Official Title
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Oxidative Stress Related to 2 Different Oxygen Concentrations During General Anesthesia. Clinical Trial.

Conditions
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Oxidative Stress

Intervention / Treatment
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* Drug: 30% of oxygen concentration.
* Drug: 60% of oxygen concentration.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective surgery, under general anesthesia. ASA 1 - 2 Orl surgery, reconstructive surgery, neck surgery, abdominal wall surgery. Exclusion Criteria: Smoking Habit Pregnancy No compensated disease. ASA 3 or Higher.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxygen 30%<br>Patient receives 1 hour of general anesthesia with a 30% oxygen concentration. | Drug: 30% of oxygen concentration.<br>* 30% oxygen concentration during one hour of general anesthesia.<br>|
| Experimental: Oxygen 60%<br>Patient receives 1 hour of general anesthesia with a 60% oxygen concentration. | Drug: 60% of oxygen concentration.<br>* 60% oxygen concentration during one hour of general anesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Malondialdehyde level | A blood sample is obtained before general anesthesia and a second sample is obtained one hour after the oxygen concentration has been fixed in the anesthesia machine. | Baseline and after one hour of general anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in proteic oxidation level | A blood sample is obtained before general anesthesia and a second sample is obtained one hour after the oxygen concentration has been fixed in the anesthesia machine. | Baseline and after one hour of general anesthesia. | 
| Change in glutathion level | A blood sample is obtained before general anesthesia and a second sample is obtained one hour after the oxygen concentration has been fixed in the anesthesia machine. | Baseline and after one hour of general anesthesia. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxidative Stress, Oxygen, General Anesthesia