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.
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Adult patients (aged 18 years or older) admitted to the intensive care unit (ICU) who require continuous sedation with propofol during mechanical ventilation. All patients are hemodynamically stable at the time of sedation initiation and are expected to require sedation for at least 24 hours. Patients are managed according to standard ICU protocols, including daily sedation assessments and monitoring with the Bispectral Index (BIS) and Riker Sedation-Agitation Scale.
Cohort
Prospective
propofol
DrugPropofol will be administered via a target-controlled infusion (TCI) system for sedation of mechanically ventilated ICU patients. Two pharmacokinetic models, Eleveld and Schnider, will be used to guide the infusion. Sedation depth will be titrated to achieve a Riker Sedation-Agitation Scale score between 3 and 4 and a Bispectral Index (BIS) value of 60-80. Hemodynamic parameters, total propofol dose, awakening time, and incidence of delirium will be recorded for comparison between models. No other sedative or hypnotic agents will be used during the study period.
TCI Propofol Injection
DevicePropofol will be administered intravenously via a target-controlled infusion (TCI) system for sedation of mechanically ventilated intensive care unit (ICU) patients. The infusion will be guided by two different pharmacokinetic models - Eleveld and Schnider - assigned to respective patient groups. The TCI device automatically adjusts infusion rates to maintain target effect-site concentrations according to each model. Sedation depth will be titrated to maintain a Riker Sedation-Agitation Scale score of 3-4 and a Bispectral Index (BIS) value between 60 and 80. Hemodynamic variables, awakening time, and delirium incidence will be evaluated to compare clinical performance between the two models.
Accuracy of Sedation Depth Control Measured by BIS Values
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
Accuracy of Sedation Depth Control Measured by BIS Values
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.
Proportion of Time Within Target Sedation Range (Riker Score 3-4)
Percentage of total sedation time during which patients remained within the target Riker Sedation-Agitation Scale (SAS) range of 3-4, comparing the Eleveld and Schnider TCI propofol models.
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