NCT07586189 Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
| NCT ID | NCT07586189 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istanbul University |
| Condition | Spinal (Fusion) Surgery |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-05-18 |
| Primary Completion | 2026-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2026-05-18 with a primary completion date of 2026-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07586189 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spinal (Fusion) Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07586189 currently recruiting?
Yes, NCT07586189 is actively recruiting participants. Contact the research team at tugceaydin1@gmail.com for enrollment information.
Where is the NCT07586189 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07586189 clinical trial?
NCT07586189 is sponsored by Istanbul University. The trial plans to enroll 50 participants.