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.
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.
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 group | Role | What they receive |
|---|---|---|
| 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. 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 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 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.
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)
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
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
Time to discharge.
patients' medical records will be reviewed.
Measured: 24 hours
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.
- First posted9 Dec 2025
- Study start1 Feb 2026
- Primary completionFeb 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Doha A Elgamal, MBBCh, MSc, Principal investigator, Ain Shams University
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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07271459
- Acronym / sponsor ID
- FMASU MD256/2025
- Conditions
- Anesthesia
- Keywords
- TIVA, Inhalational Anesthesia, Inflammatory Markers
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIVA group (group A) in which both propofol and dexmedetomidine will be used together | Active comparator | 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: DexmedetomidineGroup 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 (group B) | Active comparator | 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: SevofluraneGroup 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (13 listed)
- Patient's refusal.
- ASA > II
- Complicated hernia.
- Previous hernia repair with mesh.
- History of allergy to any of the study drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venous blood sampling preoperatively5 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 | Diagnostic test | Sevoflurane group (group B), TIVA group (group A) in which both propofol and dexmedetomidine will be used together |
| Venous blood sampling at 6 hours postoperative5 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 | Diagnostic test | Sevoflurane group (group B), TIVA group (group A) in which both propofol and dexmedetomidine will be used together |
| Venous blood sampling at 24 hours postoperative5 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 | Diagnostic test | Sevoflurane group (group B), TIVA group (group A) in which both propofol and dexmedetomidine will be used together |
| PropofolGroup 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. | Drug | TIVA group (group A) in which both propofol and dexmedetomidine will be used together |
| DexmedetomidineGroup 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. | Drug | TIVA group (group A) in which both propofol and dexmedetomidine will be used together |
| SevofluraneGroup 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 | Drug | Sevoflurane group (group B) |
Primary outcome
IL-6 level 24 hours postoperatively compared to baseline value
Time frame: 24 hours
Venous blood samples will be withdrawn aseptically at 3 time points (preoperative, 6 hours postoperative, and 24 hours postoperative)
4 secondary outcomes
Trend of change of IL-6 level within the postoperative 24 hours.
Time frame: 24 hours
Trends of change and levels of CRP, NLR, and ferritin 24 hours postoperatively.
Time frame: 24 hours
Time to discharge.
Time frame: 24 hours
Incidence of PONV.
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the study results will be made available upon reasonable request from qualified researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doha A Elgamal, MBBCh, MSc principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
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.