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NOT YET RECRUITING
NCT07644260

Transition From Sevoflurane to Total Intravenous Anesthesia in Pediatric Patients

Sponsor: Hospital de Clinicas José de San Martín

View on ClinicalTrials.gov

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.

Official title: Observational Analysis of the Transition From Inhalational Anesthesia to Total Intravenous Anesthesia Guided by Bispectral Index and the Eleveld Model in Pediatric Patients

Key Details

Gender

All

Age Range

2 Years - 12 Years

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2026-05-26

Completion Date

2027-03-28

Last Updated

2026-06-12

Healthy Volunteers

No

Locations (2)

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