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

This trial does not accept healthy volunteers

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 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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

50 Participants
are grouped into 1 trial group
Group A: Pediatric patients undergoing sevoflurane to TIVA transition

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

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)
2

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.
3

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
4

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

Other outcomes

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 contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: