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Which sedation is safer for Kids' heart procedures? new study aims to find out

NCT ID NCT07669012

Symptom relief Sponsor: Ain Shams University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compares two drug combinations (ketamine with propofol vs. dexmedetomidine with propofol) for sedating children aged 2-12 during a heart catheterization to close simple heart defects. The goal is to see which approach causes fewer breathing problems and provides smoother recovery. 124 children will be enrolled to help doctors choose the best sedation method.

What this could mean

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

Active substance
Ketamine-Propofol and Dexmedetomidine-Propofol
What this could lead to
If successful, this could identify a safer sedation method for children undergoing heart procedures, reducing breathing complications.
What could go wrong
This is a small, early-phase study, so results may not apply to all children. Both sedation methods carry risks like breathing problems or low blood pressure.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 124 people

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

Started

Oct 2025

Expected to finish

Feb 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.

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 2-12 years, male or female * Weight ≥ 10 kg * Scheduled for elective transcatheter device closure of a simple left-to-right shunt, including: * Secundum atrial septal defect (ASD) suitable for device closure * Small muscular ventricular septal defect (VSD) eligible for percutaneous device closure * Patent ductus arteriosus (PDA) closure * Procedure performed with transthoracic or transesophageal echocardiographic guidance according to the cardiology team's practice * ASA physical status II-III * Written informed consent obtained from a parent or legal guardian Exclusion Criteria: * Cyanotic congenital heart disease * Complex congenital cardiac lesions * Risk of pulmonary hypertensive crisis * Requirement for general anesthesia and cuffed endotracheal tube at the discretion of the cardiology or anesthesia team * Baseline oxygen requirement \> 2 L/min * Use of noninvasive ventilation * Known allergy or intolerance to ketamine, dexmedetomidine, or propofol * Significant hepatic impairment * Significant renal impairment * Advanced atrioventricular block * Clinically significant bradyarrhythmia * Uncontrolled epilepsy * Raised intracranial pressure * Severe obstructive sleep apnea * Craniofacial anomalies associated with anticipated difficult airway management * BMI \> 97th percentile when judged to confer high risk of sedation-related airway obstruction * Current beta-blocker use * Current clonidine use * Acute upper respiratory tract infection within 2 weeks before the procedure * Emergency or add-on procedures * Anticipated procedure duration \< 20 minutes * Anticipated procedure duration \> 3 hours

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Conditions

The condition(s) this trial relates to.

agnosia atrial septal defect, ostium secundum type patent ductus arteriosus ventricular septal defect

As listed by the trial registrant

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

Sedation and analgesia

How to take part

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

  1. The places running it

    1 site. 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

  • Ain shams university hospital

    RECRUITING

    Cairo, Egypt

More trials for these conditions

Other studies related to the condition(s) this trial covers.