Comparison of Eleveld and Schnider Models for Target-Controlled Infusion of Propofol in Intensive Care Unit Sedation
概览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Accuracy of Sedation Depth Control Measured by BIS Values
概览
简要总结
This prospective observational study aims to compare the clinical performance of two target-controlled infusion (TCI) models, Eleveld and Schnider, for propofol sedation in mechanically ventilated intensive care unit (ICU) patients. The study evaluates sedation depth, hemodynamic stability, and recovery profiles using the Bispectral Index (BIS) and Riker Sedation-Agitation Scale. Secondary outcomes include awakening time, total propofol dose, and incidence of delirium after sedation withdrawal. The findings may help identify the most reliable pharmacokinetic model for safe and effective ICU sedation.
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
- •Age over 18 years,
- •Classified as ASA (American Society of Anesthesiologists physical status) class I-IV,
- •Being monitored in the Anesthesiology and Reanimation Intensive Care Unit of Hacettepe University Faculty of Medicine Hospital,
- •Availability of necessary data (medical history, laboratory results, etc.) for analysis,
- •Hemodynamic stability -
排除标准
- •Patients who refused to participate in the study or did not provide legal consent,
- •Patients with an ASA (American Society of Anesthesiologists physical status) classification greater than IV,
- •Transition to an alternative sedation method during the study,
- •Contraindication to propofol infusion (e.g., propofol anaphylaxis, lipid metabolism disorders),
- •Patients whose sedation level could not be clinically assessed due to neurological or neurodegenerative diseases,
- •Patients expected to require sedation for more than 72 hours (to reduce the risk of propofol infusion syndrome)
研究组 & 干预措施
Eleveld Model Group
Patients sedated with propofol using the Eleveld pharmacokinetic model via a target-controlled infusion (TCI) system. Sedation will be titrated to maintain a Riker Sedation-Agitation Scale score between 3 and 4 and a Bispectral Index (BIS) value of 60-80. Hemodynamic variables, awakening time, and total propofol dose will be recorded for comparison with the Schnider group.
干预措施: propofol (Drug)
Eleveld Model Group
Patients sedated with propofol using the Eleveld pharmacokinetic model via a target-controlled infusion (TCI) system. Sedation will be titrated to maintain a Riker Sedation-Agitation Scale score between 3 and 4 and a Bispectral Index (BIS) value of 60-80. Hemodynamic variables, awakening time, and total propofol dose will be recorded for comparison with the Schnider group.
干预措施: TCI Propofol Injection (Device)
Schnider Model Group
Patients sedated with propofol using the Schnider pharmacokinetic model via a target-controlled infusion (TCI) system. Sedation depth and hemodynamic parameters will be monitored using the same protocol as in the Eleveld group. BIS values, Riker scores, and recovery profiles will be compared to assess pharmacodynamic and clinical performance between models.
干预措施: propofol (Drug)
Schnider Model Group
Patients sedated with propofol using the Schnider pharmacokinetic model via a target-controlled infusion (TCI) system. Sedation depth and hemodynamic parameters will be monitored using the same protocol as in the Eleveld group. BIS values, Riker scores, and recovery profiles will be compared to assess pharmacodynamic and clinical performance between models.
干预措施: TCI Propofol Injection (Device)
结局指标
主要结局
Accuracy of Sedation Depth Control Measured by BIS Values
时间窗: During the sedation period (up to 72 hours)
Comparison of the accuracy and stability of target-controlled infusion (TCI) sedation between the Eleveld and Schnider pharmacokinetic models in mechanically ventilated ICU patients. Sedation depth will be assessed by Bispectral Index (BIS) monitoring and maintained between 60 and 80. The mean absolute deviation of BIS from target range will be calculated to evaluate model performance.
次要结局
- Proportion of Time Within Target Sedation Range (Riker Score 3-4)(During the sedation period (up to 72 hours))
研究者
Duygu Özdemir Şimşek
Medical resident in anesthesiology
Hacettepe University