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Brain-Wave monitoring may sharpen anesthesia switch in kids

NCT ID NCT07644260

Knowledge-focused Sponsor: Hospital de Clinicas José de San Martín Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study watches how children aged 2 to 12 transition from inhaled anesthesia to intravenous anesthesia during surgery. Doctors use a brain-wave monitor (BIS) to guide the switch and track how much medication is needed. The goal is to better understand the process and improve safety for young patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
propofol and remifentanil
What this could lead to
If successful, this could help anesthesiologists tailor intravenous anesthesia more precisely for children, potentially reducing risks and improving recovery.
What could go wrong
This is a small observational study, so findings may not apply to all children or surgeries. It describes patterns rather than testing a new treatment, so direct benefits are uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

2 to 12 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anesthesia Pediatric anesthesia Total intravenous anesthesia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital General de Niños Pedro de Elizalde

    C.a.b.a., C.a.b.a., 1270, Argentina

  • Hospital de Clinicas Jose de San Martin

    C.a.b.a., C.a.b.a., 1881, Argentina

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