his prospective, observational, exploratory, and multicenter study aims to describe the evolution of propofol effect-site concentration administered via target-controlled infusion (TCI) based on the Eleveld model-with adjustments for opioid co-administration-guided by the bispectral index (BIS) during the transition from inhalational anesthesia with sevoflurane to total intravenous anesthesia (TIVA) in pediatric patients.The study population will include 50 pediatric patients, aged 2 to 12 years, scheduled for elective low- or medium-complexity surgeries. Induction will be performed with sevoflurane, followed by intravenous access placement and transition to TIVA using propofol and remifentanil via TCI. As part of the neuromonitoring, the bispectral index, spectral edge frequency (SEF), and median frequency (MF) will be recorded. Additionally, hemodynamic parameters will be recorded on a minute-by-minute basis.The primary objective is to describe BIS-guided adjustments of propofol during the anesthetic transition. Secondary objectives include describing interindividual variability in propofol titration, time to reach a BIS of 40-60, burst suppression patterns, SEF, MF, drug consumption, hemodynamic stability, and clinical adverse events. Statistical analysis will be primarily descriptive, examining correlations between BIS, propofol, and the minimum alveolar concentration (MAC) of sevoflurane.
Study Type
OBSERVATIONAL
Enrollment
50
Hospital General de Niños Pedro de Elizalde
C.a.b.a., C.a.b.a., Argentina
Hospital de Clinicas Jose de San Martin
C.a.b.a., C.a.b.a., Argentina
Temporal evolution of propofol effect-site concentration under Eleveld-model TCI during anesthetic transition
Pattern of propofol effect-site concentration (Ce) adjustments (mcg/mL) over time during the transition from sevoflurane inhalation anesthesia to TIVA. Propofol is administered via target-controlled infusion using the Eleveld pharmacokinetic-pharmacodynamic model with adjustment for opioid co-administration. Ce values are titrated under BIS-guided monitoring to maintain BIS between 40 and 60, as a function of decreasing sevoflurane minimum alveolar concentration.
Time frame: From start of propofol infusion (T0, when sevoflurane MAC = 1.0 for age), until sevoflurane MAC = 0, or a maximum of 15 minutes, whichever occurs first.
Interindividual variability in propofol titration
Distribution of propofol effect-site concentration values required to maintain target BIS, expressed as mean, SD, median, and IQR across patients.
Time frame: Throughout the transition period (up to 15 minutes from start of propofol infusion)
Time to reach target BIS range (40-60)
Time elapsed from start of propofol infusion until BIS first reaches 40-60 (minutes).
Time frame: Up to 15 minutes from start of propofol infusion.
Time outside target BIS range
Cumulative time with BIS \<40 and BIS \>60 during transition (minutes).
Time frame: Up to 15 minutes from start of propofol infusion
Duration of cortical suppression episodes
Total time with EEG suppression detected by BIS monitor (minutes).
Time frame: Up to 15 minutes from start of propofol infusion
Spectral edge frequency (SEF) and median frequency (MF) over time
Time course of SEF and MF (Hz) recorded minute by minute from processed EEG.
Time frame: Up to 15 minutes from start of propofol infusion
Incidence of intraoperative hemodynamic adverse events
Frequency of hypotension (≥20% drop in MAP from baseline), hypertension (≥20% rise in MAP from baseline), bradycardia (HR below age-adjusted normal range), and tachycardia (HR above age-adjusted normal range).
Time frame: Up to 15 minutes from start of propofol infusion
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