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AnesthesiaNCT07271459

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

A study testing Venous blood sampling preoperatively, Venous blood sampling at 6 hours postoperative and Venous blood sampling at 24 hours postoperative in people with Anesthesia, run by Ain Shams University at 1 site in Egypt.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Anesthesia
What is being tested?
Venous blood sampling preoperatively, Venous blood sampling at 6 hours postoperative and Venous blood sampling at 24 hours postoperative
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteEgypt
Study dates
1 Feb 2026to Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Ain Shams University Hospitals

    Cairo, Cairo Governorate

Other trials in Egypt

About this study

Official title: Effect of Propofol and Dexmedetomidine-Based Total Intravenous Anesthesia Versus Sevoflurane-Based Inhalational Anesthesia on the Level of Inflammatory Markers in Patients Undergoing Inguinal Hernia Repair.

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:

Read more

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).

Read the detailed description

Aim of study: Several studies showed that the anesthetic technique can affect several postoperative outcomes including the level of inflammatory markers such as Interleukins (ILs), C-reactive protein (CRP), ferritin, and neutrophil-to-lymphocyte ratio (NLR). This study aims to compare the postoperative levels and trends of change of inflammatory markers, namely IL-6, CRP, ferritin, and NLR in patients undergoing inguinal hernia repair using propofol and dexmedetomidine-based total intravenous anesthesia (TIVA) vs sevoflurane-based inhalational anesthesia (IA).

Type of Study: Prospective, randomized, double-blind, comparative clinical study.

Study Setting: Ain Shams University hospitals, Cairo, Egypt. Study Period: 6-12 months. Study Population: Adult patients scheduled for elective inguinal hernia repair. Sampling Method: Random sampling Sample Size: Using the PASS 15 program from sample size calculation, reviewing results from the previous study (Yediyıldız et al., 2025) showed that postoperative IL-6 levels were significantly lower in the TIVA group than in the sevoflurane group 20,1±23,5 versus 54,8±45,4, based on these findings a sample size of at least 20 patients per group achieve 80% power to reject the null hypothesis of equal means when the population mean difference is μ1-μ2 = 54.8- 4 20.1 = 34.7 with standard deviations of 45.0 for group 1 and 23.5 for group 2, and with a significance level (alpha) of 0.050 using a two-sided two-sample unequal-variance t-test. Ethical Considerations: The study protocol received ethical approval from the Research Ethical Committee, Faculty of Medicine Ain Shams University. Written informed consent will be signed by all participants before starting study.

Randomization and blinding: Group allocation will be contained in sequentially numbered, sealed opaque envelopes, which will be opened by the primary investigator. The collector of blood samples and the data analyzer will be blinded about the study group.

Study Procedures:

All patients will be assessed preoperatively by careful history taking and airway examination. Complete blood count (CBC), coagulation profile, liver and kidney function tests for all patients and electrocardiogram (ECG) for patients older than 40 years of age will be reviewed from patients medical records. All patients will be admitted after completing fasting hours for both solid food and clear fluids. Upon arrival to the operating room (OR), IV access of the size 20 gauge (G) will be inserted. All patients will be monitored with a five-lead ECG, non-invasive blood pressure (NIBP) measurement and finger pulse oximetry. Baseline vital data (MAP, HR, and oxygen saturation (SO2)) will be recorded. HR and SO2 will be monitored continuously and BP will be measured every 5 minutes (min) till the end of the surgery.

All patients will be premedicated with 0.03 mg/kg IV midazolam. Preoxygenation will be performed using 100% oxygen at a fresh gas flow (FGF) of 10 L/min via face mask for 3 minutes, followed by induction of general anesthesia.

Detailed anesthetic technique followed with both groups (TIVA group and Sevoflurane group) will be mentioned in arms and interventions section.

After induction, intubation will be done for all patients using suitable size endotracheal tube (ETT). Both groups will be mechanically ventilated using volume control mode with tidal volume 7-10 ml/kg/min, positive end-expiratory pressure (PEEP) 5 cmH2O and oxygen-air mixture with fraction of inspired oxygen (FiO2) 50% and FGF of 3 L/min, and respiratory rate adjusted with target end-tidal carbon dioxide (ET CO2) 30-40 mmHg. 0.1 mg/kg IV atracurium will be given as needed to maintain muscle relaxation. 0.5 mcg/kg fentanyl will be given if HR or MAP increase ≥20% from their basal value. HR and MAP ≤20% of the basal value will be treated with needed doses of atropine and ephedrine, respectively. All patients will be extubated in the operating room and transferred to postanesthesia care unit (PACU).

Sample Collection and Laboratory Analysis:

Venous blood samples for IL-6, CRP, ferritin, and CBC 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). All laboratory analysis will be conducted at the main laboratories of Ain Shams University Hospital.

❖ The main researcher of the study will be the principal investigator responsible for the preparation and conduct of the study under supervision of the director and co-directors. Each member of the team will ensure that the study is conducted according to the protocol approved in their meetings that will be arranged on regular basis. Results of the study and any complications that might occur during the study will be recorded and reported by the principal investigator and revised by the director and co-directors. Statistical Analysis The collected data will be revised, coded and introduced to a PC using statistical package for social science (SPSS 23).

Data will be presented as mean and standard deviation (+/-SD) for quantitative parametric data, median and range for quantitative non-parametric data and as numbers and percentage for qualitative data. Suitable analysis will be done according to the type of data obtained. P< 0.05 will be considered significant.

Conditions
Anesthesia
Being tested
Venous blood sampling preoperatively, Venous blood sampling at 6 hours postoperative, Venous blood sampling at 24 hours postoperative, Propofol, Dexmedetomidine
Keywords
TIVA, Inhalational Anesthesia, Inflammatory Markers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Venous blood sampling preoperativelyDiagnostic 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

  • Venous blood sampling at 6 hours postoperativeDiagnostic 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

  • Venous blood sampling at 24 hours postoperativeDiagnostic 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

  • PropofolDrug

    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.

  • DexmedetomidineDrug

    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.

  • SevofluraneDrug

    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 groups in NCT07271459
Study groupRoleWhat they receive
TIVA group (group A) in which both propofol and dexmedetomidine will be used togetherActive comparatorGroup 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.
Receives: 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 comparatorGroup 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
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 24 hours

Secondary outcomes (4)
  1. Trend of change of IL-6 level within the postoperative 24 hours.

    Venous blood samples will be withdrawn aseptically at 3 time points for the level of inflammatory markers and patients' medical records will be reviewed for the rest of the outcomes

    Measured: 24 hours

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

    Venous blood samples will be withdrawn aseptically at 3 time points for the level of inflammatory markers.

    Measured: 24 hours

  3. Time to discharge.

    patients' medical records will be reviewed.

    Measured: 24 hours

  4. Incidence of PONV.

    patients' medical records will be reviewed.

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2025
  2. Study start1 Feb 2026
  3. Primary completionFeb 2027 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07271459
Sponsor's protocol ID
FMASU MD256/2025
Status last verified
Sep 2025
First submitted
13 Nov 2025
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the study results will be made available upon reasonable request from qualified researchers.

Questions about this trial

What is this clinical trial studying?

A study testing Venous blood sampling preoperatively, Venous blood sampling at 6 hours postoperative and Venous blood sampling at 24 hours postoperative in people with Anesthesia, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IL-6 level 24 hours postoperatively compared to baseline value (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.

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