Transition From Sevoflurane to Total Intravenous Anesthesia in Pediatric Patients

Официальное название

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

Обзор

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.

Первичные конечные точки

• Temporal evolution of propofol effect-site concentration under Eleveld-model TCI during anesthetic transition [Срок оценки: 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.]

Вторичные конечные точки (6)

• Interindividual variability in propofol titration [Срок оценки: Throughout the transition period (up to 15 minutes from start of propofol infusion)]
• Time to reach target BIS range (40-60) [Срок оценки: Up to 15 minutes from start of propofol infusion.]
• Time outside target BIS range [Срок оценки: Up to 15 minutes from start of propofol infusion]
• Duration of cortical suppression episodes [Срок оценки: Up to 15 minutes from start of propofol infusion]
• Spectral edge frequency (SEF) and median frequency (MF) over time [Срок оценки: Up to 15 minutes from start of propofol infusion]
• Incidence of intraoperative hemodynamic adverse events [Срок оценки: Up to 15 minutes from start of propofol infusion]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Аргентина · 2 центра

• Hospital General de Niños Pedro de Elizalde — C.a.b.a.
• Hospital de Clinicas Jose de San Martin — C.a.b.a.

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07644260 · PED-TIVA-TRANS · TSTP01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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