Clinical Trial

Transition From Sevoflurane to Total Intravenous Anesthesia in Pediatric Patients

Study acronym: TSTP
Not Yet Recruiting
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Summary
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.
Trial Details
NCT Number NCT07644260
Lead Sponsor Hospital de Clinicas José de San Martín
Collaborators: Medtronic
Conditions Anesthesia, Pediatric Anesthesia, Total Intravenous Anesthesia
Enrollment 50 participants
Start Date 2026-05-26
Primary Completion 2026-10-31 (estimated)
Study Completion 2027-03-28 (estimated)
Updated on ClinicalTrials.gov 2026-06-12