Transition From Sevoflurane to Total Intravenous Anesthesia in Pediatric Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-12
SponsorHospital de Clinicas José de San Martín

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

Qualifiers

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 design

Treatments tested in this trial

  • Not listed

Trial groups

50 Participants
are grouped into 1 trial group

Locations

2

Map coordinates are unavailable for these locations. Locations are shown below instead.

Hospital de Clinicas Jose de San Martin Status unavailable 1881, C.a.b.a., C.a.b.a.ArgentinaArgentina
Hospital General de Niños Pedro de Elizalde Status unavailable 1270, C.a.b.a., C.a.b.a.ArgentinaArgentina

Sponsors and collaborators