- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07586189
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
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Tugce Aydin Ozata, MD
- Numéro de téléphone: 009 0533 711 6090
- E-mail: tugceaydin1@gmail.com
Lieux d'étude
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Istanbul, Turquie (Türkiye)
- Recrutement
- Istanbul University
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Contact:
- Tugce Aydin Ozata, MD
- Numéro de téléphone: 0090 533 711 6090
- E-mail: tugceaydin1@gmail.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
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.
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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Eleveld Model
Eleveld model used patients
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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
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Mean Arterial Pressure - Physiological Parameter
Délai: 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
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Mean Arterial Pressure Changes
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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
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Heart Rate - Physiological Parameter
Délai: Heart Rate - baseline Heart Rate- induction 1. minute Heart Rate- induction 3. minute Heart Rate- induction 5. minute Heart Rate- induction 10. minute
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Heart Rate Changes
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Heart Rate - baseline Heart Rate- induction 1. minute Heart Rate- induction 3. minute Heart Rate- induction 5. minute Heart Rate- induction 10. minute
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Bisepectal Index values - Physiological Parameter, Processed EEG
Délai: baseline- intraoperative 0. minute induction - 1. minute induction- 3. minute induction- 5. minute induction- 10. Minute
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Bisepectal Index values
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baseline- intraoperative 0. minute induction - 1. minute induction- 3. minute induction- 5. minute induction- 10. Minute
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Time till BIS < 40
Délai: first 10 minutes after induction
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time period till BIS value under 40 after induction
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first 10 minutes after induction
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Response to intubation
Délai: perioperative
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Responce during intubation
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perioperative
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Burst suppression period
Délai: first 10 minutes after induction
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Burst suppression period during first 10 minutes after induction
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first 10 minutes after induction
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Hemodynamic response to intubation
Délai: first 10 minutes after induction
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Hemodynamic response to intubation ( >%20 decrease to baseline mean arterial pressure or heart rate)
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first 10 minutes after induction
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Total propofol dosage
Délai: first 5 minutes after induction
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Total propofol dosage
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first 5 minutes after induction
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Additional Propofol Dose Requirement
Délai: First 5 minutes after induction
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Additional Propofol Dose Requirement during Induction
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First 5 minutes after induction
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Total Fentanyl Dosage
Délai: perioperative
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Total Fentanyl Dosage (2mcg/kg)
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perioperative
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Total Rocuronium Dosage
Délai: perioperative
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Total Rocuronium Dosage (0.5mg/kg)
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perioperative
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Brevibloc Requirement
Délai: First 5 minutes after induction
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Brevibloc Requirement
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First 5 minutes after induction
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Period of time until Delta wave
Délai: First 10 minutes of induction period
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Period of time until Delta wave on EEG
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First 10 minutes of induction period
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Vazopressor/Inotropic Drug Requirement
Délai: first 10 minutes after induction period
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Vazopressor/Inotropic Drug Requirement during induction period
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first 10 minutes after induction period
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 2025/664
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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