Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider Target-Controlled Infusion Models. A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean Arterial Pressure
研究概览
简要总结
This randomized prospective study aims to compare the effects of two target-controlled infusion models, the Schnider and Eleveld models, on anesthetic depth and hemodynamic responses during anesthesia induction in adult patients undergoing spinal surgery.
Patients scheduled for spinal surgery will be randomized into either the Schnider or Eleveld group. Before induction, standard monitoring will be applied, including electrocardiography, peripheral oxygen saturation, invasive arterial blood pressure monitoring, heart rate monitoring, and bispectral index monitoring. Anesthesia induction will be performed with fentanyl 2 mcg/kg, rocuronium 0.6 mg/kg, and propofol administered by target-controlled infusion with an effect-site target concentration of 3 mcg/mL according to the allocated pharmacokinetic model.
Hemodynamic parameters and bispectral index values will be recorded before induction and at the 1st, 3rd, 5th, and 10th minutes after induction. Additional parameters, including time to BIS below 40, time to delta activity, burst suppression duration, total propofol dose during the first 5 minutes, need for additional propofol, hemodynamic response to intubation, vasopressor requirement within the first 10 minutes, and use of esmolol, will also be documented. The primary aim is to evaluate whether the Schnider and Eleveld models differ in terms of induction-related hemodynamic stability and anesthetic depth during the early induction period.
详细描述
This study is designed as a randomized prospective clinical study in adult patients undergoing spinal surgery. The study will evaluate and compare two pharmacokinetic models used for target-controlled infusion of propofol: the Schnider model and the Eleveld model. The main focus of the study is the first 10 minutes of anesthesia induction, a period in which rapid changes in anesthetic depth and hemodynamic variables may occur.
Eligible patients scheduled for spinal surgery will be assigned to one of two groups according to the propofol target-controlled infusion model used during induction: the Schnider group or the Eleveld group. Patients younger than 18 years, patients with uncontrolled hypertension, patients with uncontrolled diabetes mellitus, and patients who do not provide consent will be excluded.
Before anesthesia induction, demographic and clinical variables will be recorded, including age, sex, ASA physical status, height, weight, body mass index, diagnosis, type of operation, operation date, and comorbid diseases. Baseline vital signs will be obtained from the preoperative ward follow-up values and from the immediate pre-induction period.
All patients will receive standard monitoring before induction, including peripheral oxygen saturation, electrocardiography, invasive arterial blood pressure monitoring, heart rate monitoring, and bispectral index monitoring. Invasive arterial pressure monitoring will allow continuous assessment of systolic arterial pressure, diastolic arterial pressure, and mean arterial pressure during the induction period.
Anesthesia induction will be performed using fentanyl 2 mcg/kg, rocuronium 0.6 mg/kg, and propofol administered by target-controlled infusion. Propofol will be administered using the pharmacokinetic model assigned by randomization, either Schnider or Eleveld. The target-controlled infusion pump will be set to achieve an effect-site propofol concentration of 3 mcg/mL. The induction period will be evaluated during the first 10 minutes after induction.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective spinal surgery under general anesthesia
- •Patients who will undergo surgery at the Neurosurgery Department of Istanbul University, Istanbul Faculty of Medicine
- •Patients aged 18 years or older
- •Patients who provide written informed consent to participate in the study
排除标准
- •Patients with uncontrolled hypertension
- •Patients with uncontrolled diabetes mellitus
- •Patients younger than 18 years of age
- •Patients who do not provide informed consent to participate in the study
研究组 & 干预措施
Eleveld Model
Eleveld model used patients
干预措施: TCI Propofol Injection Models- Eleveld (Other)
Schnider Model
Schnider model used patients
干预措施: TCI Propofol Injection Schnider (Other)
结局指标
主要结局
Mean Arterial Pressure
时间窗: Mean Arterial Pressure - Baseline Mean Arterial Pressure - induction 1. minute Mean Arterial Pressure - induction 3. minute Mean Arterial Pressure - induction 5. minute Mean Arterial Pressure - induction 10. Minute
Mean Arterial Pressure Changes
Mean Arterial Pressure - Physiological Parameter
时间窗: Mean Arterial Pressure - Baseline Mean Arterial Pressure - induction 1. minute Mean Arterial Pressure - induction 3. minute Mean Arterial Pressure - induction 5. minute Mean Arterial Pressure - induction 10. Minute
Mean Arterial Pressure Changes
次要结局
- Heart Rate(Heart Rate - baseline Heart Rate- induction 1. minute Heart Rate- induction 3. minute Heart Rate- induction 5. minute Heart Rate- induction 10. minute)
- Bisepectal Index values(baseline- intraoperative 0. minute induction - 1. minute induction- 3. minute induction- 5. minute induction- 10. Minute)
- Heart Rate - Physiological Parameter(Heart Rate - baseline Heart Rate- induction 1. minute Heart Rate- induction 3. minute Heart Rate- induction 5. minute Heart Rate- induction 10. minute)
- Bisepectal Index values - Physiological Parameter, Processed EEG(baseline- intraoperative 0. minute induction - 1. minute induction- 3. minute induction- 5. minute induction- 10. Minute)
- Burst suppression period(first 10 minutes after induction)
- Time till BIS < 40(first 10 minutes after induction)
- Response to intubation(perioperative)
- Hemodynamic response to intubation(first 10 minutes after induction)
- Total propofol dosage(first 5 minutes after induction)
- Additional Propofol Dose Requirement(First 5 minutes after induction)
- Total Fentanyl Dosage(perioperative)
- Total Rocuronium Dosage(perioperative)
- Brevibloc Requirement(First 5 minutes after induction)
- Period of time until Delta wave(First 10 minutes of induction period)
- Vazopressor/Inotropic Drug Requirement(first 10 minutes after induction period)
研究者
Tugce Aydin Ozata
MD
Istanbul University