Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07644260

Transition From Sevoflurane to Total Intravenous Anesthesia in Pediatric Patients

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Anesthesia Pediatric Anesthesia Total Intravenous Anesthesia

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General de Niños Pedro de Elizalde, C.a.b.a., Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Temporal evolution of propofol effect-site concentration under Eleveld-model TCI during anesthetic transition

    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.

    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

  1. Interindividual variability in propofol titration

    Time frame: 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.

  2. Time to reach target BIS range (40-60)

    Time frame: Up to 15 minutes from start of propofol infusion.

    Time elapsed from start of propofol infusion until BIS first reaches 40-60 (minutes).

  3. Time outside target BIS range

    Time frame: Up to 15 minutes from start of propofol infusion

    Cumulative time with BIS <40 and BIS >60 during transition (minutes).

  4. Duration of cortical suppression episodes

    Time frame: Up to 15 minutes from start of propofol infusion

    Total time with EEG suppression detected by BIS monitor (minutes).

  5. Spectral edge frequency (SEF) and median frequency (MF) over time

    Time frame: Up to 15 minutes from start of propofol infusion

    Time course of SEF and MF (Hz) recorded minute by minute from processed EEG.

  6. Incidence of intraoperative hemodynamic adverse events

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Manuel Cuevas, MD

CONTACT

[email protected]

542494675554

Stella Verlangieri, MD

CONTACT

[email protected]

541144905757

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas José de San Martín

Other

Collaborators

  • Medtronic

Registry information

Official study title

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

Acronym: TSTP

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.