Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider

NCT07586189 | Recruiting

• 1 other identifier: 2025/664
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal (Fusion) Surgery; Total Intravenous Anesthesia; BIS-EEG; Target Controlled Infusion of Propofol; Anesthesia Depth Monitoring

Keywords

spinal surgery; total intravenous anesthesia; target controlled infusion; anesthesia depth monitoring

Outcome Measures

Primary Outcomes (1)

• Mean Arterial Pressure - Physiological Parameter

  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

Secondary Outcomes (2)

• Heart Rate - Physiological Parameter

  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

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

Study Arms (2)

Eleveld Model

Eleveld model used patients

Other: TCI Propofol Injection Models- Eleveld

Schnider Model

Schnider model used patients

Other: TCI Propofol Injection Schnider

Interventions

TCI Propofol Injection Models- Eleveld OTHER

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.

Eleveld Model

TCI Propofol Injection Schnider OTHER

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.

Schnider Model

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (7)

• Absalom AR, Schnider TW. The future of target-controlled infusion and new pharmacokinetic models. Curr Opin Anaesthesiol. 2025 Aug 1;38(4):375-381. doi: 10.1097/ACO.0000000000001529. Epub 2025 May 26.

  PMID: 40421498 BACKGROUND

• Linassi F, Zanatta P, Spano L, Burelli P, Farnia A, Carron M. Schnider and Eleveld Models for Propofol Target-Controlled Infusion Anesthesia: A Clinical Comparison. Life (Basel). 2023 Oct 16;13(10):2065. doi: 10.3390/life13102065.

  PMID: 37895446 BACKGROUND

• Safrankova P, Bruthans J. Target-Controlled Infusion of Propofol: A Systematic Review of Recent Results. J Med Syst. 2025 Apr 28;49(1):54. doi: 10.1007/s10916-025-02187-y.

  PMID: 40289063 BACKGROUND

• Lee S, Kang D, Song E, Yoo S, Jeong S. External validation of the modified Marsh and Schnider models for medium-chain triglyceride propofol in target-controlled infusion anesthesia. BMC Anesthesiol. 2024 Feb 23;24(1):70. doi: 10.1186/s12871-024-02461-5.

  PMID: 38395779 BACKGROUND

• Eleveld DJ, Colin P, Absalom AR, Struys MMRF. Pharmacokinetic-pharmacodynamic model for propofol for broad application in anaesthesia and sedation. Br J Anaesth. 2018 May;120(5):942-959. doi: 10.1016/j.bja.2018.01.018. Epub 2018 Mar 12.

  PMID: 29661412 BACKGROUND

• Vellinga R, Hannivoort LN, Introna M, Touw DJ, Absalom AR, Eleveld DJ, Struys MMRF. Prospective clinical validation of the Eleveld propofol pharmacokinetic-pharmacodynamic model in general anaesthesia. Br J Anaesth. 2021 Feb;126(2):386-394. doi: 10.1016/j.bja.2020.10.027. Epub 2020 Dec 13.

  PMID: 33317804 BACKGROUND

• Absalom AR, Glen JI, Zwart GJ, Schnider TW, Struys MM. Target-Controlled Infusion: A Mature Technology. Anesth Analg. 2016 Jan;122(1):70-8. doi: 10.1213/ANE.0000000000001009.

  PMID: 26516798 BACKGROUND

Central Study Contacts

Tugce Aydin Ozata, MD

CONTACT

009 0533 711 6090; tugceaydin1@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 14, 2026
• Study Start: May 18, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)