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Study seeks optimal ephedrine dose for Infants' low blood pressure during surgery

NCT ID NCT02384876

Symptom relief Sponsor: Hospices Civils de Lyon 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested different doses of the drug ephedrine to find the most effective one for treating low blood pressure that occurs during surgery in newborns and infants up to 6 months old. The trial involved 120 infants who developed low blood pressure while under anesthesia. Researchers compared several higher doses against a standard low dose to see which worked best.

What this could mean

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

Active substance
Ephedrine
What this could lead to
If successful, this could establish a safer, more effective dose of ephedrine for treating low blood pressure during surgery in very young infants.
What could go wrong
This is a small, early-phase study (Phase 2) with only 120 participants, so results may not apply to all infants. The study is also completed, so no new data is being collected.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

120 people

The number who actually took part.

Started

Jun 2015

Finished

Sep 2020

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.

Ages

Up to 6 months

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: * Newborns or infants \< 6 months of age, * boys and girls, * premature or not, * requiring general anesthesia induced by sevoflurane * who presents during anesthesia a decrease of blood pressure superior to 20% of the basal mBP (measured prior to surgery) despite of vascular filling with sodium chloride 0.9% (10mL/kg during 10 min). * Written, informed consent obtained from the 2 parents Exclusion Criteria: * Allergy to Ephedrine. * Emergency surgery. * Patient having previously received other vasopressive amines. * Use of other indirect sympathomimetic drug such as phenylpropanolamine, phenylephrine, pseudoephedrine and methylphenidate. * Premedication with clonidine * Congenital heart disease * IV-induced anesthesia.

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As listed by the trial registrant

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

Infant, newborn Intraoperative arterial hypotension

Contacts and locations

Locations

  • Hospices Civils de Lyon

    Lyon, France

  • Hôpital Nord

    Saint-Etienne, 42055, France

  • Hôpital d'Estaing

    Clermont-Ferrand, 63003, France

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