Clinical Trial

Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider

Recruiting
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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.
Protocol Amendment History 2 changes
critical Recruitment opened 2026-05-21
critical Primary endpoint(s) modified 2026-05-21
Trial Details
NCT Number NCT07586189
Lead Sponsor Istanbul University
Conditions Spinal (Fusion) Surgery, Total Intravenous Anesthesia, Target Controlled Infusion of Propofol, Anesthesia Depth Monitoring, BIS-EEG
Enrollment 50 participants
Start Date 2026-05-18
Primary Completion 2026-07-30 (estimated)
Study Completion 2026-08-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-03