Immunologic Effect of Fraction of Inspired Oxygen
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: hyperoxygenation group Intraoperative administration of a mixture of 80% oxygen and 20% air |
Other: fraction of inspired oxygen
after induction of general anaesthesia, different fraction of inspired oxygen will be given to patient according to their group allocation
|
| Placebo Comparator: control group intraoperative administration of 30% oxygen and 70% air |
Other: fraction of inspired oxygen
after induction of general anaesthesia, different fraction of inspired oxygen will be given to patient according to their group allocation
|
Outcome Measures
Primary Outcome Measures
- changes in serum level of interlukin 6 [before operation (0), 1st, 3rd, and 7th days postoperative]
serum level of interlukin 6 will be measured by ELISA technique
- changes in serum level of interlukin 10 [before operation (0), 1st, 3rd, and 7th days postoperative]
serum level of interlukin 6 will be measured by ELISA technique
Secondary Outcome Measures
- changes in total WBCs count [before operation (0), 1st, 3rd, and 7th days postoperative]
measurement of total white blood cells count
Eligibility Criteria
Criteria
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,
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severe malnutrition (albumin <3),
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leukopenia (white blood cell <4,000 g/dL),
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surgery within the previous 30 days and
-
O2 saturation < 90%, as measured using a pulse oximeter
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Assiut University | Assiut | Egypt | 171516 |
Sponsors and Collaborators
- Assiut University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 519