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Immunologic Effect of Fraction of Inspired Oxygen

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04772794
Enrollment
20
Registered
2021-02-26
Start date
2020-01-13
Completion date
2022-05-31
Last updated
2021-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune System

Keywords

fraction of inspired oxygen, hyperoxia, immune system

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.

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.

Interventions

after induction of general anaesthesia, different fraction of inspired oxygen will be given to patient according to their group allocation

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
changes in serum level of interlukin 6before operation (0), 1st, 3rd, and 7th days postoperativeserum level of interlukin 6 will be measured by ELISA technique
changes in serum level of interlukin 10before operation (0), 1st, 3rd, and 7th days postoperativeserum level of interlukin 6 will be measured by ELISA technique

Secondary

MeasureTime frameDescription
changes in total WBCs countbefore operation (0), 1st, 3rd, and 7th days postoperativemeasurement of total white blood cells count

Countries

Egypt

Contacts

Primary ContactShereen M Kamal, Associate Professor
sheridouh79@yahoo.com01006279209

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026