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Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07586189
Enrollment
50
Registered
2026-05-14
Start date
2026-05-18
Completion date
2026-08-30
Last updated
2026-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Detailed description

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.

Interventions

OTHERTCI 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.

OTHERTCI 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.

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mean Arterial Pressure - Physiological ParameterMean 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. MinuteMean Arterial Pressure Changes

Secondary

MeasureTime frameDescription
Heart Rate - Physiological ParameterHeart Rate - baseline Heart Rate- induction 1. minute Heart Rate- induction 3. minute Heart Rate- induction 5. minute Heart Rate- induction 10. minuteHeart Rate Changes
Bisepectal Index values - Physiological Parameter, Processed EEGbaseline- intraoperative 0. minute induction - 1. minute induction- 3. minute induction- 5. minute induction- 10. MinuteBisepectal Index values
Time till BIS < 40first 10 minutes after inductiontime period till BIS value under 40 after induction
Response to intubationperioperativeResponce during intubation
Burst suppression periodfirst 10 minutes after inductionBurst suppression period during first 10 minutes after induction
Hemodynamic response to intubationfirst 10 minutes after inductionHemodynamic response to intubation ( \>%20 decrease to baseline mean arterial pressure or heart rate)
Total propofol dosagefirst 5 minutes after inductionTotal propofol dosage
Additional Propofol Dose RequirementFirst 5 minutes after inductionAdditional Propofol Dose Requirement during Induction
Total Fentanyl DosageperioperativeTotal Fentanyl Dosage (2mcg/kg)
Total Rocuronium DosageperioperativeTotal Rocuronium Dosage (0.5mg/kg)
Brevibloc RequirementFirst 5 minutes after inductionBrevibloc Requirement
Period of time until Delta waveFirst 10 minutes of induction periodPeriod of time until Delta wave on EEG
Vazopressor/Inotropic Drug Requirementfirst 10 minutes after induction periodVazopressor/Inotropic Drug Requirement during induction period

Countries

Turkey (Türkiye)

Contacts

CONTACTTugce Aydin Ozata, MD
tugceaydin1@gmail.com009 0533 711 6090

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 19, 2026