Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider

Condition(s) studied

Investigational drug(s) / intervention(s)

TCI Propofol Injection Models- Eleveld: Patients in this group will receive propofol for anesthetic induction using target-controlled infusion based on the Eleveld pharmacokinetic/pharmacodynamic model. Standard monitoring will include electrocardiography, peripheral oxygen saturation, invasive arterial blood pressure, heart rate, and bispectral index monitoring. Fentanyl 2 mcg/kg and rocuronium 0.6 mg/kg will be administered according to the study protocol. Hemodynamic variables and BIS values will be recorded before induction and at 1, 3, 5, and 10 minutes after induction.

TCI Propofol Injection Schnider: Patients randomized to the Schnider group will receive propofol for anesthetic induction using target-controlled infusion based on the Schnider pharmacokinetic/pharmacodynamic model. Propofol will be administered via a TCI system according to the study protocol. Standard monitoring will include electrocardiography, peripheral oxygen saturation, invasive arterial blood pressure, heart rate, and bispectral index monitoring. Fentanyl 2 mcg/kg and rocuronium 0.6 mg/kg will be administered as part of the standardized induction protocol. Hemodynamic variables and BIS values will be recorded before induction and at 1, 3, 5, and 10 minutes after induction.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Mean Arterial Pressure - Physiological Parameter — 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

Trial sites (1)

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