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.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- IL-6 level 24 hours postoperatively compared to baseline value
研究概览
简要总结
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).
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Collector of blood samples and data analyzer
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Patient's refusal.
- •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.
研究组 & 干预措施
TIVA group (group A) in which both propofol and dexmedetomidine will be used together
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.
干预措施: Propofol (Drug)
TIVA group (group A) in which both propofol and dexmedetomidine will be used together
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.
干预措施: Dexmedetomidine (Drug)
Sevoflurane group (group B)
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
干预措施: Sevoflurane (Drug)
TIVA group (group A) in which both propofol and dexmedetomidine will be used together
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.
干预措施: Venous blood sampling preoperatively (Diagnostic Test)
TIVA group (group A) in which both propofol and dexmedetomidine will be used together
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.
干预措施: Venous blood sampling at 6 hours postoperative (Diagnostic Test)
TIVA group (group A) in which both propofol and dexmedetomidine will be used together
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.
干预措施: Venous blood sampling at 24 hours postoperative (Diagnostic Test)
Sevoflurane group (group B)
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
干预措施: Venous blood sampling at 6 hours postoperative (Diagnostic Test)
Sevoflurane group (group B)
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
干预措施: Venous blood sampling at 24 hours postoperative (Diagnostic Test)
Sevoflurane group (group B)
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
干预措施: Venous blood sampling preoperatively (Diagnostic Test)
结局指标
主要结局
IL-6 level 24 hours postoperatively compared to baseline value
时间窗: 24 hours
Venous blood samples will be withdrawn aseptically at 3 time points (preoperative, 6 hours postoperative, and 24 hours postoperative)
次要结局
- Trend of change of IL-6 level within the postoperative 24 hours.(24 hours)
- Incidence of PONV.(24 hours)
- Trends of change and levels of CRP, NLR, and ferritin 24 hours postoperatively.(24 hours)
- Time to discharge.(24 hours)