Transition From Sevoflurane to Total Intravenous Anesthesia in Pediatric Patients

NCT07644260 | Not Yet Recruiting

• 2 other identifiers: PED-TIVA-TRANSTSTP01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Anesthesia; Pediatric Anesthesia; Total Intravenous Anesthesia

Keywords

Total Intravenous Anesthesia; TIVA; Bispectral Index; BIS; Propofol; Sevoflurane; Eleveld; Target-Controlled Infusion; TCI; Pediatric Anesthesia; Anesthesia Transition

Outcome Measures

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.

  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 (6)

• Interindividual variability in propofol titration

  Throughout the transition period (up to 15 minutes from start of propofol infusion)

• Time to reach target BIS range (40-60)

  Up to 15 minutes from start of propofol infusion.

• Time outside target BIS range

  Up to 15 minutes from start of propofol infusion

• Duration of cortical suppression episodes

  Up to 15 minutes from start of propofol infusion

• Spectral edge frequency (SEF) and median frequency (MF) over time

  Up to 15 minutes from start of propofol infusion

Study Arms (1)

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.

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Clinicas José de San Martín: lead
• Medtronic: collaborator

Study Sites (2)

Hospital General de Niños Pedro de Elizalde

C.a.b.a., C.a.b.a., 1270, Argentina

Location

Hospital de Clinicas Jose de San Martin

C.a.b.a., C.a.b.a., 1881, Argentina

Location

Related Publications (11)

• Eleveld DJ, Proost JH, Vereecke H, Absalom AR, Olofsen E, Vuyk J, Struys MMRF. An Allometric Model of Remifentanil Pharmacokinetics and Pharmacodynamics. Anesthesiology. 2017 Jun;126(6):1005-1018. doi: 10.1097/ALN.0000000000001634.

  PMID: 28509794 BACKGROUND

• Degoute CS, Macabeo C, Dubreuil C, Duclaux R, Banssillon V. EEG bispectral index and hypnotic component of anaesthesia induced by sevoflurane: comparison between children and adults. Br J Anaesth. 2001 Feb;86(2):209-12. doi: 10.1093/bja/86.2.209.

  PMID: 11573661 BACKGROUND

• Kreuer S, Wilhelm W. The Narcotrend monitor. Best Pract Res Clin Anaesthesiol. 2006 Mar;20(1):111-9. doi: 10.1016/j.bpa.2005.08.010.

  PMID: 16634418 BACKGROUND

• McFarlan CS, Anderson BJ, Short TG. The use of propofol infusions in paediatric anaesthesia: a practical guide. Paediatr Anaesth. 1999;9(3):209-16.

  PMID: 10320599 BACKGROUND

• Dennhardt N, Boethig D, Beck C, Heiderich S, Boehne M, Leffler A, Schultz B, Sumpelmann R. Optimization of initial propofol bolus dose for EEG Narcotrend Index-guided transition from sevoflurane induction to intravenous anesthesia in children. Paediatr Anaesth. 2017 Apr;27(4):425-432. doi: 10.1111/pan.13118. Epub 2017 Feb 18.

  PMID: 28213945 BACKGROUND

• Nimmo AF, Absalom AR, Bagshaw O, Biswas A, Cook TM, Costello A, Grimes S, Mulvey D, Shinde S, Whitehouse T, Wiles MD. Guidelines for the safe practice of total intravenous anaesthesia (TIVA): Joint Guidelines from the Association of Anaesthetists and the Society for Intravenous Anaesthesia. Anaesthesia. 2019 Feb;74(2):211-224. doi: 10.1111/anae.14428. Epub 2018 Oct 31.

  PMID: 30378102 BACKGROUND

• Davidson AJ, Sale SM, Wong C, McKeever S, Sheppard S, Chan Z, Williams C. The electroencephalograph during anesthesia and emergence in infants and children. Paediatr Anaesth. 2008 Jan;18(1):60-70. doi: 10.1111/j.1460-9592.2007.02359.x.

  PMID: 18095968 BACKGROUND

• Lee JM, Akeju O, Terzakis K, Pavone KJ, Deng H, Houle TT, Firth PG, Shank ES, Brown EN, Purdon PL. A Prospective Study of Age-dependent Changes in Propofol-induced Electroencephalogram Oscillations in Children. Anesthesiology. 2017 Aug;127(2):293-306. doi: 10.1097/ALN.0000000000001717.

  PMID: 28657957 BACKGROUND

• Purdon PL, Sampson A, Pavone KJ, Brown EN. Clinical Electroencephalography for Anesthesiologists: Part I: Background and Basic Signatures. Anesthesiology. 2015 Oct;123(4):937-60. doi: 10.1097/ALN.0000000000000841.

  PMID: 26275092 BACKGROUND

• Vellinga R, Hannivoort LN, Introna M, Touw DJ, Absalom AR, Eleveld DJ, Struys MMRF. Prospective clinical validation of the Eleveld propofol pharmacokinetic-pharmacodynamic model in general anaesthesia. Br J Anaesth. 2021 Feb;126(2):386-394. doi: 10.1016/j.bja.2020.10.027. Epub 2020 Dec 13.

  PMID: 33317804 BACKGROUND

• Eleveld DJ, Colin P, Absalom AR, Struys MMRF. Pharmacokinetic-pharmacodynamic model for propofol for broad application in anaesthesia and sedation. Br J Anaesth. 2018 May;120(5):942-959. doi: 10.1016/j.bja.2018.01.018. Epub 2018 Mar 12.

  PMID: 29661412 BACKGROUND

Study Officials

• Manuel Cuevas, MD

  Hospital de Clinicas Jose de San Martin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuel Cuevas, MD

CONTACT

542494675554; manuel.cuevas@anestesiologo.org

Stella Verlangieri, MD

CONTACT

541144905757; sverlangieri@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: June 12, 2026
• Study Start: May 26, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): March 28, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

AR (2)