Effect of Total Intravenous Anesthesia vs Inhalational Anesthesia on the Level of Inflammatory Markers

NCT07271459 | Not Yet Recruiting

• 1 other identifier: FMASU MD256/2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Anesthesia

Keywords

TIVA; Inhalational Anesthesia; Inflammatory Markers

Outcome Measures

Primary Outcomes (1)

• IL-6 level 24 hours postoperatively compared to baseline value

  Venous blood samples will be withdrawn aseptically at 3 time points (preoperative, 6 hours postoperative, and 24 hours postoperative)

  24 hours

Secondary Outcomes (4)

• Trend of change of IL-6 level within the postoperative 24 hours.

  24 hours

• Trends of change and levels of CRP, NLR, and ferritin 24 hours postoperatively.

  24 hours

• Time to discharge.

  24 hours

• Incidence of PONV.

  24 hours

Study Arms (2)

TIVA group (group A) in which both propofol and dexmedetomidine will be used together

ACTIVE COMPARATOR

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.

Diagnostic Test: Venous blood sampling preoperatively; Diagnostic Test: Venous blood sampling at 6 hours postoperative; Diagnostic Test: Venous blood sampling at 24 hours postoperative; Drug: Propofol; Drug: Dexmedetomidine

Sevoflurane group (group B)

ACTIVE COMPARATOR

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

Diagnostic Test: Venous blood sampling preoperatively; Diagnostic Test: Venous blood sampling at 6 hours postoperative; Diagnostic Test: Venous blood sampling at 24 hours postoperative; Drug: Sevoflurane

Interventions

Propofol DRUG

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.

TIVA group (group A) in which both propofol and dexmedetomidine will be used together

Venous blood sampling preoperatively DIAGNOSTIC_TEST

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

Sevoflurane group (group B); TIVA group (group A) in which both propofol and dexmedetomidine will be used together

Venous blood sampling at 6 hours postoperative DIAGNOSTIC_TEST

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

Sevoflurane group (group B); TIVA group (group A) in which both propofol and dexmedetomidine will be used together

Venous blood sampling at 24 hours postoperative DIAGNOSTIC_TEST

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

Sevoflurane group (group B); TIVA group (group A) in which both propofol and dexmedetomidine will be used together

Dexmedetomidine DRUG

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.

TIVA group (group A) in which both propofol and dexmedetomidine will be used together

Sevoflurane DRUG

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

Sevoflurane group (group B)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients between 18 and 50 years of age undergoing elective inguinal hernia repair.
• American Society of Anesthesiologists physical status classification (ASA) I and II.

You may not qualify if:

• Patient's refusal.
• ASA \> II
• Complicated hernia.
• Previous hernia repair with mesh.
• History of allergy to any of the study drugs.
• History of any heart disease affecting cardiac function or rhythm or receiving medications that decrease the heart rate (HR).
• Baseline HR≤60 beat/min.
• Baseline mean arterial pressure (MAP)≤70 mmHg.
• Psychiatric illness.
• Patients with chronic kidney or liver disease. (Creatinine clearance\<50 mL/min or serum albumin level\<2g/dL.)
• Patients with immunological disorders or receiving immunosuppressive treatment or anti-inflammatory drugs.
• Patients with neoplasms, chronic inflammatory states, or active infections.
• Patients with any type of anemia or those who received iron therapy or blood transfusion within 4 weeks.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Interventions

Propofol; Dexmedetomidine; Sevoflurane

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Doha A Elgamal, MBBCh, MSc

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Doha Elgamal, MBBCh, MSc

CONTACT

+201122271196; Dohaatef@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Collector of blood samples
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: December 9, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within 6-12 months and for up to 5 years
• Access Criteria: Access will be granted to researchers who submit a methodologically sound proposal to the principal investigator. Requests should be directed to dohaatef@med.asu.edu.eg

Locations

EG (1)