Immunologic Effect of Fraction of Inspired Oxygen

Study Overview
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Brief Summary
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During anesthesia and surgery, oxygen is routinely administered to all patients. Inspired oxygen concentrations, however, vary between 30% - 100% and oxygen is often administered in a seemingly random manner.

Detailed Description
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During anesthesia and surgery, oxygen is routinely administered to all patients. Inspired oxygen concentrations, however, vary between 30% - 100% and oxygen is often administered in a seemingly random manner.A striking conundrum is evident immediately when one review studies on the effects of oxygen on cytokines synthesis. Most investigators have found that hyperoxia enhances proinflammtory cytokines transcription and translations (11). In contrast, hyperparic oxygen has generally been shown to suppress stimulus induced porinflammtory cytokine production (12). Other studies have demonstrated that supplemental oxygen improves inflammatory and immune function (13), and it is not associated with clinically important side effect (14). We therefor undertook the current prospective randomized study to investigate whether perioperative supplemental oxygen (30% versus 80%) on pro and anti-inflammatory response in patients undergoing major abdominal cancer surgeries as our primary outcome.

Official Title
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Immunological Effect of Intraoperative Fraction of Inspired Oxygen in Patients Undergoing Major Abdominal Cancer Surgery

Conditions
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Immune System

Intervention / Treatment
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* Other: fraction of inspired oxygen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: candidates for abdominal cancer surgeries Exclusion Criteria: Patients with chronic diseases, such as chronic obstructive pulmonary disease or pneumonia, body mass index (BMI) >35 kg/m2, severe malnutrition (albumin <3), leukopenia (white blood cell <4,000 g/dL), surgery within the previous 30 days and O2 saturation < 90%, as measured using a pulse oximeter

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: hyperoxygenation group<br>Intraoperative administration of a mixture of 80% oxygen and 20% air | Other: fraction of inspired oxygen<br>* after induction of general anaesthesia, different fraction of inspired oxygen will be given to patient according to their group allocation<br>|
| Placebo Comparator: control group<br>intraoperative administration of 30% oxygen and 70% air | Other: fraction of inspired oxygen<br>* after induction of general anaesthesia, different fraction of inspired oxygen will be given to patient according to their group allocation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in serum level of interlukin 6 | serum level of interlukin 6 will be measured by ELISA technique | before operation (0), 1st, 3rd, and 7th days postoperative | 
| changes in serum level of interlukin 10 | serum level of interlukin 6 will be measured by ELISA technique | before operation (0), 1st, 3rd, and 7th days postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in total WBCs count | measurement of total white blood cells count | before operation (0), 1st, 3rd, and 7th days postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fraction of inspired oxygen, hyperoxia, immune system