Immunologic Effect of Fraction of Inspired Oxygen

Immune System Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04772794
• Other study ID #: 519
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Immune System
• Respiratory Aspiration

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