Transition From Sevoflurane to Total Intravenous Anesthesia in Pediatric Patients (TSTP)

June 8, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
    • C.a.b.a.
      • C.a.b.a., C.a.b.a., Argentina, 1270
        • Hospital General de Niños Pedro de Elizalde
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gonzalo Alberto Tejeda, MD
        • Sub-Investigator:
          • Nicolas Alejandro Rizza, MD
      • C.a.b.a., C.a.b.a., Argentina, 1881
        • Hospital de Clinicas Jose de San Martin
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Francisco Bornet, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Temporal evolution of propofol effect-site concentration under Eleveld-model TCI during anesthetic transition
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interindividual variability in propofol titration
Time Frame: Throughout the transition period (up to 15 minutes from start of propofol infusion)
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)
Time Frame: Up to 15 minutes from start of propofol infusion.
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
Time Frame: Up to 15 minutes from start of propofol infusion
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
Time Frame: Up to 15 minutes from start of propofol infusion
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 Frame: Up to 15 minutes from start of propofol infusion
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
Time Frame: Up to 15 minutes from start of propofol infusion
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas José de San Martín

Collaborators

Medtronic

Investigators

  • Principal Investigator: Manuel Cuevas, MD, Hospital de Clinicas Jose de San Martin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 26, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

March 28, 2027

Study Registration Dates

First Submitted

May 6, 2026

First Submitted That Met QC Criteria

June 8, 2026

First Posted (Actual)

June 12, 2026

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PED-TIVA-TRANS
  • TSTP01 (Other Identifier: Hospital de Clínicas José de San Martín)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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