Transition From Sevoflurane to Total Intravenous Anesthesia in Pediatric Patients (TSTP)
2026年6月8日 更新者：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.
研究概览
研究类型
观察性的
注册 (估计的)
50
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Manuel Cuevas, MD
- 电话号码：542494675554
- 邮箱：manuel.cuevas@anestesiologo.org
研究联系人备份
- 姓名：Stella Verlangieri, MD
- 电话号码：541144905757
- 邮箱：sverlangieri@gmail.com
学习地点
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C.a.b.a.
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C.a.b.a.、C.a.b.a.、阿根廷、1270
- Hospital General de Niños Pedro de Elizalde
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接触：
- Gonzalo Alberto Tejeda, MD
- 电话号码：+54 9 2314 47-3867
- 邮箱：gonzalotejedamed@gmail.com
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接触：
- Nicolas Alejandro Rzza, MD
- 电话号码：+54 9 11 6010-7126
- 邮箱：nicolas.alejandro.rizza@gmail.com
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首席研究员：
- Gonzalo Alberto Tejeda, MD
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副研究员：
- Nicolas Alejandro Rizza, MD
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C.a.b.a.、C.a.b.a.、阿根廷、1881
- Hospital de Clinicas Jose de San Martin
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接触：
- Manuel Cuevas, MD
- 电话号码：02494675554
- 邮箱：manuel.cuevas@anestesiologo.org
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接触：
- Stella Verlangieri, MD
- 电话号码：54 9 11 4490-5757
- 邮箱：sverlangieri@gmail.com
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副研究员：
- Francisco Bornet, MD
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
不
取样方法
非概率样本
研究人群
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.
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Temporal evolution of propofol effect-site concentration under Eleveld-model TCI during anesthetic transition
大体时间：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.
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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.
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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.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Interindividual variability in propofol titration
大体时间：Throughout the transition period (up to 15 minutes from start of propofol infusion)
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Distribution of propofol effect-site concentration values required to maintain target BIS, expressed as mean, SD, median, and IQR across patients.
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Throughout the transition period (up to 15 minutes from start of propofol infusion)
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Time to reach target BIS range (40-60)
大体时间：Up to 15 minutes from start of propofol infusion.
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Time elapsed from start of propofol infusion until BIS first reaches 40-60 (minutes).
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Up to 15 minutes from start of propofol infusion.
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Time outside target BIS range
大体时间：Up to 15 minutes from start of propofol infusion
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Cumulative time with BIS <40 and BIS >60 during transition (minutes).
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Up to 15 minutes from start of propofol infusion
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Duration of cortical suppression episodes
大体时间：Up to 15 minutes from start of propofol infusion
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Total time with EEG suppression detected by BIS monitor (minutes).
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Up to 15 minutes from start of propofol infusion
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Spectral edge frequency (SEF) and median frequency (MF) over time
大体时间：Up to 15 minutes from start of propofol infusion
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Time course of SEF and MF (Hz) recorded minute by minute from processed EEG.
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Up to 15 minutes from start of propofol infusion
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Incidence of intraoperative hemodynamic adverse events
大体时间：Up to 15 minutes from start of propofol infusion
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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).
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Up to 15 minutes from start of propofol infusion
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Manuel Cuevas, MD、Hospital de Clinicas Jose de San Martin
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
- 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.
- 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.
- McFarlan CS, Anderson BJ, Short TG. The use of propofol infusions in paediatric anaesthesia: a practical guide. Paediatr Anaesth. 1999;9(3):209-16.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年5月26日
初级完成 (估计的)
2026年10月31日
研究完成 (估计的)
2027年3月28日
研究注册日期
首次提交
2026年5月6日
首先提交符合 QC 标准的
2026年6月8日
首次发布 (实际的)
2026年6月12日
研究记录更新
最后更新发布 (实际的)
2026年6月12日
上次提交的符合 QC 标准的更新
2026年6月8日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他研究编号
- PED-TIVA-TRANS
- TSTP01 (其他标识符：Hospital de Clínicas José de San Martín)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
IPD 计划说明
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.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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