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New study: sedation may be as safe as general anesthesia for Kids' heart procedure

NCT ID NCT06431178

Symptom relief Sponsor: Tanta University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 60 children aged 3-8 years who needed a procedure to close a hole in their heart. Researchers compared general anesthesia to a lighter sedation combined with numbing medicine at the catheter site. They measured heart rate and blood pressure to see which approach caused fewer changes during the procedure.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

60 people

The number who actually took part.

Started

May 2024

Finished

Aug 2025

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

3 to 8 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: * Aged 3-8 years old. * Both genders. * American Society of Anesthesiologists (ASA) physical status II-III * Pediatric patients scheduled for elective transcatheter atrial septal defect closure. Exclusion Criteria: * Patients with multiple congenital anomalies. * Patients with congestive heart failure * Patients with Organ dysfunction liver or renal disease or pulmonary disease. * Recent chest infection. * Airway abnormalities.

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Conditions

The condition(s) this trial relates to.

atrial septal defect

As listed by the trial registrant

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

Atrial septal defect Dexmedetomidine General anesthesia Ketamine Local infiltration

Contacts and locations

Locations

  • Aya Ebrahim Abdelhafez Mashal

    Tanta, El-Gharbia Governorate, Egypt, 31527, Egypt

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