About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 2 to 12 years
Scheduled for elective low- or intermediate-risk surgery according to the National Institute for Health and Care Excellence (NICE) surgical risk stratification (e.g., tonsillectomy, adenoidectomy, postioplasty, orchidectomy, orchidopexy, inguinal herniorrhaphy)
American Society of Anesthesiologists (ASA) Physical Status Classification I or II
Disqualifiers
Refusal of parents/legal guardians to sign informed consent, or refusal of the child to provide assent when applicable
Cardiovascular or neurological disease that may interfere with anesthesia or with the pharmacokinetic model
History of allergy or adverse reaction to inhalational or intravenous anesthetic agents used in the protocol
Airway malformations or conditions that complicate standard intubation or airway management
Trial population
Pediatric patients aged 2 to 12 years scheduled for elective low- or intermediate-risk surgery at Hospital de Clínicas José de San Martín and Hospital General de Niños Pedro de Elizalde, Buenos Aires, Argentina. Recruitment will aim for balanced representation across three age strata (2 to \<4 years, 4 to \<8 years, and 8 to 12 years), although age stratification is not an inclusion criterion. Patients will be enrolled by consecutive non-probability sampling over an estimated 4-month period, with a target sample size of 50 participants.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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 to reach target BIS range (40-60)
Time elapsed from start of propofol infusion until BIS first reaches 40-60 (minutes).
Time outside target BIS range
Cumulative time with BIS \<40 and BIS \>60 during transition (minutes).
Duration of cortical suppression episodes
Total time with EEG suppression detected by BIS monitor (minutes).
Locations
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Sponsors and contacts
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Hospital de Clinicas José de San Martín
Lead sponsor
Medtronic
Collaborator
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