Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstanbul University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

The study population will consist of adult patients scheduled for elective spinal surgery under general anesthesia at the Neurosurgery Department of Istanbul University, Istanbul Faculty of Medicine. Eligible patients will be 18 years of age or older and will provide written informed consent before enrollment. Patients with uncontrolled hypertension, uncontrolled diabetes mellitus, those younger than 18 years of age, and patients who do not provide consent will be excluded from the study. Eligible participants will be randomized to receive propofol target-controlled infusion using either the Schnider or Eleveld model for anesthetic induction. Hemodynamic parameters and bispectral index values will be evaluated during the first 10 minutes of the induction period.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • TCI Propofol Injection Models- Eleveld

    Other intervention

    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

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Eleveld Model1 intervention
Group B: Schnider Model1 intervention

Trial outcomes

Primary outcomes

1

Mean Arterial Pressure - Physiological Parameter

Mean Arterial Pressure Changes

Time frame
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

Secondary outcomes

1

Heart Rate - Physiological Parameter

Heart Rate Changes

Time frame
Heart Rate - baseline Heart Rate- induction 1. minute Heart Rate- induction 3. minute Heart Rate- induction 5. minute Heart Rate- induction 10. minute
2

Bisepectal Index values - Physiological Parameter, Processed EEG

Bisepectal Index values

Time frame
baseline- intraoperative 0. minute induction - 1. minute induction- 3. minute induction- 5. minute induction- 10. Minute
3

Time till BIS < 40

time period till BIS value under 40 after induction

Time frame
first 10 minutes after induction
4

Response to intubation

Responce during intubation

Time frame
perioperative

Other outcomes

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