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| ID | Type | Description | Link |
|---|---|---|---|
| TSTP01 | Other Identifier | Hospital de Clínicas José de San Martín |
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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Interindividual variability in propofol titration | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manuel Cuevas, MD | Contact | 542494675554 | manuel.cuevas@anestesiologo.org | |
| Stella Verlangieri, MD | Contact | 541144905757 | sverlangieri@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Manuel Cuevas, MD | Hospital de Clinicas Jose de San Martin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de Niños Pedro de Elizalde | C.a.b.a. | C.a.b.a. | 1270 | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28509794 | Background | 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. | |
| 11573661 | 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. |
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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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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 | 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 | 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 | 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 | 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 |
| Hospital de Clinicas Jose de San Martin | C.a.b.a. | C.a.b.a. | 1881 | Argentina |
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| 16634418 | 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. |
| 10320599 | 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. |
| 28213945 | 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. |
| 30378102 | 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. |
| 18095968 | 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. |
| 28657957 | 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. |
| 26275092 | 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. |
| 33317804 | 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. |
| 29661412 | 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. |