Anesthesia, Pediatric Anesthesia, Total Intravenous Anesthesia
Conditions
Keywords
Total Intravenous Anesthesia, TIVA, Bispectral Index, BIS, Propofol, Sevoflurane, Eleveld, Target-Controlled Infusion, TCI, Pediatric Anesthesia, Anesthesia Transition
Brief 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.
Interventions
None listed
Sponsors
Hospital de Clinicas José de San Martín
Medtronic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Psychological or neurological conditions requiring sedative or hypnotic premedication prior to the anesthetic procedure * Treatment with drugs that may alter the pharmacokinetics or pharmacodynamics of the anesthetic agents * Difficult peripheral venous access
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Temporal evolution of propofol effect-site concentration under Eleveld-model TCI during anesthetic transition | 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| Interindividual variability in propofol titration | Throughout the transition period (up to 15 minutes from start of propofol infusion) | 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) | Up to 15 minutes from start of propofol infusion. | Time elapsed from start of propofol infusion until BIS first reaches 40-60 (minutes). |
| Time outside target BIS range | Up to 15 minutes from start of propofol infusion | Cumulative time with BIS \<40 and BIS \>60 during transition (minutes). |
| Duration of cortical suppression episodes | Up to 15 minutes from start of propofol infusion | Total time with EEG suppression detected by BIS monitor (minutes). |
| Spectral edge frequency (SEF) and median frequency (MF) over time | Up to 15 minutes from start of propofol infusion | Time course of SEF and MF (Hz) recorded minute by minute from processed EEG. |
| Incidence of intraoperative hemodynamic adverse events | Up to 15 minutes from start of propofol infusion | Frequency of hypotension (≥20% drop in MAP from baseline), hypertension (≥20% rise in MAP from baseline), bradycardia (HR below age-adjusted normal range), and tachycardia (HR above age-adjusted normal range). |
Countries
Argentina
Contacts
CONTACTManuel Cuevas, MD
CONTACTStella Verlangieri, MD
PRINCIPAL_INVESTIGATORManuel Cuevas, MD
Hospital de Clinicas Jose de San Martin
Outcome results
None listed