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Transition From Sevoflurane to Total Intravenous Anesthesia in Pediatric Patients (TSTP)

8. juni 2026 opdateret af: Manuel Cuevas, Hospital de Clinicas José de San Martín

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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

50

Kontakter og lokationer

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Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Argentina
    • C.a.b.a.
      • C.a.b.a., C.a.b.a., Argentina, 1270
        • Hospital General de Niños Pedro de Elizalde
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Gonzalo Alberto Tejeda, MD
        • Underforsker:
          • Nicolas Alejandro Rizza, MD
      • C.a.b.a., C.a.b.a., Argentina, 1881
        • Hospital de Clinicas Jose de San Martin
        • Kontakt:
        • Kontakt:
        • Underforsker:
          • Francisco Bornet, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Pediatric patients undergoing sevoflurane to TIVA transition
Pediatric patients aged 2-12 years scheduled for elective low or intermediate risk surgery, undergoing standard sevoflurane mask induction followed by transition to total intravenous anesthesia with propofol via target-controlled infusion (Eleveld model) and remifentanil, guided by Bispectral Index monitoring.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Temporal evolution of propofol effect-site concentration under Eleveld-model TCI during anesthetic transition
Tidsramme: 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.
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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Interindividual variability in propofol titration
Tidsramme: 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.
Throughout the transition period (up to 15 minutes from start of propofol infusion)
Time to reach target BIS range (40-60)
Tidsramme: Up to 15 minutes from start of propofol infusion.
Time elapsed from start of propofol infusion until BIS first reaches 40-60 (minutes).
Up to 15 minutes from start of propofol infusion.
Time outside target BIS range
Tidsramme: Up to 15 minutes from start of propofol infusion
Cumulative time with BIS <40 and BIS >60 during transition (minutes).
Up to 15 minutes from start of propofol infusion
Duration of cortical suppression episodes
Tidsramme: Up to 15 minutes from start of propofol infusion
Total time with EEG suppression detected by BIS monitor (minutes).
Up to 15 minutes from start of propofol infusion
Spectral edge frequency (SEF) and median frequency (MF) over time
Tidsramme: Up to 15 minutes from start of propofol infusion
Time course of SEF and MF (Hz) recorded minute by minute from processed EEG.
Up to 15 minutes from start of propofol infusion
Incidence of intraoperative hemodynamic adverse events
Tidsramme: 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).
Up to 15 minutes from start of propofol infusion

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hospital de Clinicas José de San Martín

Samarbejdspartnere

Medtronic

Efterforskere

  • Ledende efterforsker: Manuel Cuevas, MD, Hospital de Clinicas Jose de San Martin

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

26. maj 2026

Primær færdiggørelse (Anslået)

31. oktober 2026

Studieafslutning (Anslået)

28. marts 2027

Datoer for studieregistrering

Først indsendt

6. maj 2026

Først indsendt, der opfyldte QC-kriterier

8. juni 2026

Først opslået (Faktiske)

12. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • PED-TIVA-TRANS
  • TSTP01 (Anden identifikator: Hospital de Clínicas José de San Martín)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

A formal individual participant data (IPD) sharing plan has not yet been established. The current informed consent and assent forms approved by the Ethics Committees do not specifically authorize sharing of individual-level data with third parties; only aggregated, anonymized results are planned for dissemination through scientific publications and conference presentations. A decision regarding IPD sharing may be reconsidered after study completion, subject to ethics committee approval, additional consent provisions if required, and a formal data sharing agreement.

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