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Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider

15 augustus 2026 bijgewerkt door: Tugce Aydin Ozata, Istanbul University

Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider Target-Controlled Infusion Models. A Randomized 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.

Studie Overzicht

Gedetailleerde beschrijving

This study is designed as a randomized prospective clinical study in adult patients undergoing spinal surgery. The study will evaluate and compare two pharmacokinetic models used for target-controlled infusion of propofol: the Schnider model and the Eleveld model. The main focus of the study is the first 10 minutes of anesthesia induction, a period in which rapid changes in anesthetic depth and hemodynamic variables may occur.

Eligible patients scheduled for spinal surgery will be assigned to one of two groups according to the propofol target-controlled infusion model used during induction: the Schnider group or the Eleveld group. Patients younger than 18 years, patients with uncontrolled hypertension, patients with uncontrolled diabetes mellitus, and patients who do not provide consent will be excluded.

Before anesthesia induction, demographic and clinical variables will be recorded, including age, sex, ASA physical status, height, weight, body mass index, diagnosis, type of operation, operation date, and comorbid diseases. Baseline vital signs will be obtained from the preoperative ward follow-up values and from the immediate pre-induction period.

All patients will receive standard monitoring before induction, including peripheral oxygen saturation, electrocardiography, invasive arterial blood pressure monitoring, heart rate monitoring, and bispectral index monitoring. Invasive arterial pressure monitoring will allow continuous assessment of systolic arterial pressure, diastolic arterial pressure, and mean arterial pressure during the induction period.

Anesthesia induction will be performed using fentanyl 2 mcg/kg, rocuronium 0.6 mg/kg, and propofol administered by target-controlled infusion. Propofol will be administered using the pharmacokinetic model assigned by randomization, either Schnider or Eleveld. The target-controlled infusion pump will be set to achieve an effect-site propofol concentration of 3 mcg/mL. The induction period will be evaluated during the first 10 minutes after induction.

Heart rate, mean arterial pressure, systolic arterial pressure, diastolic arterial pressure, and BIS values will be recorded at predefined time points: ward baseline, immediately before induction, and at the 1st, 3rd, 5th, and 10th minutes after induction. The presence of a hemodynamic response to intubation will be assessed according to whether heart rate or mean arterial pressure increases by more than 20% compared with ward measurements. Patient movement or straining during intubation will also be recorded as none, mild, or severe.

In addition to routine hemodynamic and BIS measurements, several induction-related variables will be documented. These include the time required for BIS to decrease below 40, the time until delta activity is observed, burst suppression duration, total propofol dose during the first 5 minutes, need for additional propofol, total fentanyl and rocuronium doses, and whether esmolol was used, including its dose. The requirement for vasopressor therapy within the first 10 minutes, including the agent and dose used, will also be recorded.

During the first 10 minutes of induction, magnesium administration will not be performed in order to avoid potential confounding effects on hemodynamic parameters. Throughout the operation, the patient's hemodynamic stability will be observed, and any additional drug requirements will be documented.

The primary objective of the study is to compare the Schnider and Eleveld target-controlled infusion models in terms of hemodynamic changes and anesthetic depth during the first 10 minutes of anesthesia induction. Secondary evaluations will include the incidence of intubation-related hemodynamic response, time to BIS below 40, burst suppression duration, need for additional propofol, vasopressor requirement, and total propofol dose during early induction.

Studietype

Observationeel

Inschrijving (Geschat)

50

Contacten en locaties

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Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Eleveld Model
Eleveld model used patients
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.
Schnider Model
Schnider model used patients
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mean Arterial Pressure - Physiological Parameter
Tijdsspanne: 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
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Heart Rate - Physiological Parameter
Tijdsspanne: Heart Rate - baseline Heart Rate- induction 1. minute Heart Rate- induction 3. minute Heart Rate- induction 5. minute Heart Rate- induction 10. minute
Heart Rate Changes
Heart Rate - baseline Heart Rate- induction 1. minute Heart Rate- induction 3. minute Heart Rate- induction 5. minute Heart Rate- induction 10. minute
Bisepectal Index values - Physiological Parameter, Processed EEG
Tijdsspanne: baseline- intraoperative 0. minute induction - 1. minute induction- 3. minute induction- 5. minute induction- 10. Minute
Bisepectal Index values
baseline- intraoperative 0. minute induction - 1. minute induction- 3. minute induction- 5. minute induction- 10. Minute
Time till BIS < 40
Tijdsspanne: first 10 minutes after induction
time period till BIS value under 40 after induction
first 10 minutes after induction
Response to intubation
Tijdsspanne: perioperative
Responce during intubation
perioperative
Burst suppression period
Tijdsspanne: first 10 minutes after induction
Burst suppression period during first 10 minutes after induction
first 10 minutes after induction
Hemodynamic response to intubation
Tijdsspanne: first 10 minutes after induction
Hemodynamic response to intubation ( >%20 decrease to baseline mean arterial pressure or heart rate)
first 10 minutes after induction
Total propofol dosage
Tijdsspanne: first 5 minutes after induction
Total propofol dosage
first 5 minutes after induction
Additional Propofol Dose Requirement
Tijdsspanne: First 5 minutes after induction
Additional Propofol Dose Requirement during Induction
First 5 minutes after induction
Total Fentanyl Dosage
Tijdsspanne: perioperative
Total Fentanyl Dosage (2mcg/kg)
perioperative
Total Rocuronium Dosage
Tijdsspanne: perioperative
Total Rocuronium Dosage (0.5mg/kg)
perioperative
Brevibloc Requirement
Tijdsspanne: First 5 minutes after induction
Brevibloc Requirement
First 5 minutes after induction
Period of time until Delta wave
Tijdsspanne: First 10 minutes of induction period
Period of time until Delta wave on EEG
First 10 minutes of induction period
Vazopressor/Inotropic Drug Requirement
Tijdsspanne: first 10 minutes after induction period
Vazopressor/Inotropic Drug Requirement during induction period
first 10 minutes after induction period

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Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

18 mei 2026

Primaire voltooiing (Werkelijk)

15 augustus 2026

Studie voltooiing (Geschat)

30 augustus 2026

Studieregistratiedata

Eerst ingediend

8 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

8 mei 2026

Eerst geplaatst (Werkelijk)

14 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

18 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

15 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

The clinical data of this trial are available upon reasonable request to the corresponding author.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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