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Clinical Trials in Egypt / NCT07271459
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Effect of Total Intravenous Anesthesia vs Inhalational Anesthesia on the Level of Inflammatory Markers

NCT07271459 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2026-02-01
Last updated
2026-09-16

Condition(s) studied

Anesthesia

Investigational drug(s) / intervention(s)

Venous blood sampling preoperativelyVenous blood sampling at 6 hours postoperativeVenous blood sampling at 24 hours postoperativePropofol →Dexmedetomidine →Sevoflurane →

Venous blood sampling preoperatively: 5 mL of venous blood will be aseptically withdrawn into a sterile plain tube. Serum interleukin-6 (IL-6) levels will be measured using the enzyme-linked immunosorbent assay (ELISA) method. Ferritin and C-reactive protein (CRP) concentrations will be analyzed using a COBAS automated analyzer. Additionally, a 2 mL blood sample will be collected in an EDTA tube for complete blood count (CBC) analysis, which will be performed using the Sysmex Coulter hematology analyzer

Venous blood sampling at 6 hours postoperative: 5 mL of venous blood will be aseptically withdrawn into a sterile plain tube. Serum interleukin-6 (IL-6) levels will be measured using the enzyme-linked immunosorbent assay (ELISA) method. Ferritin and C-reactive protein (CRP) concentrations will be analyzed using a COBAS automated analyzer. Additionally, a 2 mL blood sample will be collected in an EDTA tube for complete blood count (CBC) analysis, which will be performed using the Sysmex Coulter hematology analyzer

Venous blood sampling at 24 hours postoperative: 5 mL of venous blood will be aseptically withdrawn into a sterile plain tube. Serum interleukin-6 (IL-6) levels will be measured using the enzyme-linked immunosorbent assay (ELISA) method. Ferritin and C-reactive protein (CRP) concentrations will be analyzed using a COBAS automated analyzer. Additionally, a 2 mL blood sample will be collected in an EDTA tube for complete blood count (CBC) analysis, which will be performed using the Sysmex Coulter hematology analyzer

Propofol: Group A (TIVA group): will receive 1 μg/kg IV dexmedetomidine over 10 min, 1 μg/kg IV fentanyl, 2 mg/kg IV propofol, and 0.5 mg/kg IV atracurium. Maintenance of anesthesia will be achieved by 0.5 μg/kg/h dexmedetomidine IV infusion and 6-12 mg/kg/h propofol IV infusion titrated according to bispectral index value (BIS) with target BIS 40-60.

Dexmedetomidine: Group A (TIVA group): will receive 1 μg/kg IV dexmedetomidine over 10 min, 1 μg/kg IV fentanyl, 2 mg/kg IV propofol, and 0.5 mg/kg IV atracurium. Maintenance of anesthesia will be achieved by 0.5 μg/kg/h dexmedetomidine IV infusion and 6-12 mg/kg/h propofol IV infusion titrated according to bispectral index value (BIS) with target BIS 40-60.

Sevoflurane: Group B (Sevoflurane group): will receive 1 μg/kg IV fentanyl, 8% sevoflurane via face mask and 0.5 mg/kg IV atracurium. Maintenance of anesthesia will be achieved with 2%-4% sevoflurane titrated according to BIS with target BIS 40-60

Study summary

This study aims to compare the effects of total intravenous anesthesia (TIVA) vs inhalational anesthesia on postoperative levels of inflammatory markers, length of hospital stay, and the incidence of postoperative nausea and vomiting in patients undergoing inguinal hernia repair.

Number participants:

Participants will be divided into 2 groups with sample size of at least 20 patients per group.

Plan of the work:

All patients will receive general anesthesia according to Ain Shams hospital protocol which follows the standards of the American Society of Anesthesiologists. Group A will be TIVA group and Group B will be Sevoflurane group.

Sample Collection and Laboratory Analysis:

Venous blood samples will be collected from each patient at three time points:

preoperative (baseline, sample 0), 6 hours postoperative (sample 1), and 24 hours postoperative (sample 2).

Eligibility

Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Adult patients between 18 and 50 years of age undergoing elective inguinal hernia repair. 2. American Society of Anesthesiologists physical status classification (ASA) I and II. Exclusion Criteria: 1. Patient's refusal. 2. ASA \> II 3. Complicated hernia. 4. Previous hernia repair with mesh. 5. History of allergy to any of the study drugs. 6. History of any heart disease affecting cardiac function or rhythm or receiving medications that decrease the heart rate (HR). 7. Baseline HR≤60 beat/min. 8. Baseline mean arterial pressure (MAP)≤70 mmHg. 9. Psychiatric illness. 10. Patients with chronic kidney or liver disease. (Creatinine clearance\<50 mL/min or serum albumin level\<2g/dL.) 11. Patients with immunological disorders or receiving immunosuppressive treatment or anti-inflammatory drugs. 12. Patients with neoplasms, chronic inflammatory states, or active infections. 13. Patients with any type of anemia or those who received iron therapy or blood transfusion within 4 weeks.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Ain Shams University Hospitals Cairo Cairo Governorate

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07271459 on ClinicalTrials.gov ↗ ← All trials in Egypt