Transition From Sevoflurane to Total Intravenous Anesthesia in Pediatric Patients (TSTP)
2026년 6월 8일 업데이트: 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.
연구 개요
연구 유형
관찰
등록 (추정된)
50
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Manuel Cuevas, MD
- 전화번호: 542494675554
- 이메일: manuel.cuevas@anestesiologo.org
연구 연락처 백업
- 이름: Stella Verlangieri, MD
- 전화번호: 541144905757
- 이메일: sverlangieri@gmail.com
연구 장소
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C.a.b.a.
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C.a.b.a., C.a.b.a., 아르헨티나, 1270
- Hospital General de Niños Pedro de Elizalde
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연락하다:
- Gonzalo Alberto Tejeda, MD
- 전화번호: +54 9 2314 47-3867
- 이메일: gonzalotejedamed@gmail.com
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연락하다:
- Nicolas Alejandro Rzza, MD
- 전화번호: +54 9 11 6010-7126
- 이메일: nicolas.alejandro.rizza@gmail.com
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수석 연구원:
- Gonzalo Alberto Tejeda, MD
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부수사관:
- Nicolas Alejandro Rizza, MD
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C.a.b.a., C.a.b.a., 아르헨티나, 1881
- Hospital de Clinicas Jose de San Martin
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연락하다:
- Manuel Cuevas, MD
- 전화번호: 02494675554
- 이메일: manuel.cuevas@anestesiologo.org
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연락하다:
- Stella Verlangieri, MD
- 전화번호: 54 9 11 4490-5757
- 이메일: sverlangieri@gmail.com
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부수사관:
- Francisco Bornet, MD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Temporal evolution of propofol effect-site concentration under Eleveld-model TCI during anesthetic transition
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Interindividual variability in propofol titration
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Manuel Cuevas, MD, Hospital de Clinicas Jose de San Martin
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 5월 26일
기본 완료 (추정된)
2026년 10월 31일
연구 완료 (추정된)
2027년 3월 28일
연구 등록 날짜
최초 제출
2026년 5월 6일
QC 기준을 충족하는 최초 제출
2026년 6월 8일
처음 게시됨 (실제)
2026년 6월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 8일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- PED-TIVA-TRANS
- TSTP01 (기타 식별자: Hospital de Clínicas José de San Martín)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .