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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04772794
Other study ID # 519
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 13, 2020
Est. completion date May 2022

Study information

Verified date February 2021
Source Assiut University
Contact Shereen M Kamal, Associate Professor
Phone 01006279209
Email sheridouh79@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date May 2022
Est. primary completion date January 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Assiut University Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 changes in total WBCs count measurement of total white blood cells count before operation (0), 1st, 3rd, and 7th days postoperative
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