The future of target-controlled infusion and new pharmacokinetic models.
Anthony R Absalom, Thomas W Schnider
https://pubmed.ncbi.nlm.nih.gov/40421498Actively Recruiting
Age: 18Years +
All Genders
ID07586189
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider Target-Controlled Infusion Models. A Randomized Trial
Led by Istanbul University · Updated on 2026-05-20
50
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of two different target-controlled infusion (TCI) models, the Schnider and Eleveld models, on anesthetic depth and blood pressure responses during anesthesia induction in adults undergoing spinal surgery. The study specifically focuses on the first 10 minutes after induction, a critical period for changes in anesthetic depth and hemodynamic stability. This randomized prospective clinical study aims to compare these models to understand their impact on anesthesia management during spinal surgery. Patients scheduled for elective spinal surgery will be randomly assigned to receive propofol anesthesia induction using either the Schnider or Eleveld TCI model. Before induction, standard monitoring will be applied, including electrocardiography, oxygen saturation, invasive arterial blood pressure, heart rate, and bispectral index (BIS) monitoring. Anesthesia induction will include fentanyl 2 mcg/kg, rocuronium 0.6 mg/kg, and propofol administered by TCI set to reach an effect-site concentration of 3 mcg/mL according to the assigned model. Hemodynamic and BIS measurements will be taken at baseline and at 1, 3, 5, and 10 minutes after induction. Additional data such as time to BIS below 40, burst suppression duration, total propofol dose, need for extra propofol, and vasopressor or esmolol use during the first 10 minutes will also be collected. Participants will have demographic and clinical information recorded before surgery. During the study, heart rate, various blood pressure measures, and BIS values will be closely monitored at set times. The study will assess the anesthetic depth and hemodynamic responses, including reactions to intubation. Researchers will also document any additional drug requirements and vasopressor usage. The primary outcome is the mean arterial pressure at several time points within the first 10 minutes post-induction. Overall participation includes monitoring during the early anesthesia induction phase to compare these two infusion models.
CONDITIONS
Brief Title
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility and consent
Treatment
Duration - Up to 10 minutes during anesthesia induction
Participants undergo anesthesia induction for spinal surgery using one of two propofol target-controlled infusion models (Eleveld or Schnider). Standard monitoring and hemodynamic measurements are taken before and during the first 10 minutes of induction.
1 induction visit during surgery
Monitoring
Duration - Duration of the surgery
Participants' hemodynamic stability and anesthetic depth are observed throughout the surgery with documentation of any additional drug requirements.
Continuous monitoring during surgery
Trial Site Locations
Total: 1 location
1
Istanbul University
Istanbul, Turkey (Türkiye)
Actively Recruiting
Loading map...
Research Team
T
Tugce Aydin Ozata, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Schnider and Eleveld Models for Propofol Target-Controlled Infusion Anesthesia: A Clinical Comparison.
Federico Linassi, Paolo Zanatta, Leonardo Spano...
https://pubmed.ncbi.nlm.nih.gov/37895446Target-Controlled Infusion of Propofol: A Systematic Review of Recent Results.
Pavla Šafránková, Jan Bruthans
https://pubmed.ncbi.nlm.nih.gov/40289063External validation of the modified Marsh and Schnider models for medium-chain triglyceride propofol in target-controlled infusion anesthesia.
Seongheon Lee, Dongho Kang, Eunjin Song...
https://pubmed.ncbi.nlm.nih.gov/38395779Pharmacokinetic-pharmacodynamic model for propofol for broad application in anaesthesia and sedation.
D J Eleveld, P Colin, A R Absalom...
https://pubmed.ncbi.nlm.nih.gov/29661412Prospective clinical validation of the Eleveld propofol pharmacokinetic-pharmacodynamic model in general anaesthesia.
Remco Vellinga, Laura N Hannivoort, Michele Introna...
https://pubmed.ncbi.nlm.nih.gov/33317804Target-Controlled Infusion: A Mature Technology.
Anthony R Absalom, John Iain B Glen, Gerrit J C Zwart...
https://pubmed.ncbi.nlm.nih.gov/26516798