Ketamine-Propofol vs Dexmedetomidine-Propofol Sedation for Pediatric Cardiac Catheterization

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional Phase 1 trial compares ketamine-propofol with dexmedetomidine-propofol sedation in children undergoing transcatheter device closure of simple left-to-right shunts. Eligible participants are 2–12 years old, weighing at least 10 kg, with ASA II-III status, and scheduled for elective closure of conditions such as ASD, small muscular VSD, or PDA. Procedures may be guided by transthoracic or transesophageal echocardiography per the cardiology team's practice. The study aims to assess safety and efficacy of the two sedation regimens during the catheterization procedure. Lead sponsor is Ain Shams University, with procedures conducted at Ain Shams University Hospital in Cairo, Egypt.

Why it matters

Who can join: the full rules

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

Where it's running

• Ain shams university hospital
  Cairo, Egypt Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Impact of Anesthesia on Inflammation and NETosis During HCC Ablation

  This study tests whether a propofol–fentanyl anesthesia plan with lidocaine during radiofrequency ablation for hepatocellular carcinoma affects inflammation and NETosis in patients with small tumors.

  Recruiting Iuliu Hatieganu University of Medicine and Pharmacy · Cluj-Napoca, Cluj · NCT07657897

• IR-led deep ketamine sedation for select image-guided procedures

  We will try deep ketamine sedation instead of general anesthesia for adults having certain image-guided interventional radiology procedures.

  Recruiting Phase 1/2 CAMC Health System · Charleston, West Virginia · NCT07443254

• Cannabis use and IV sedation during wisdom tooth removal

  This project will see if people who use cannabis need different IV sedative doses or have different vital signs and breathing during wisdom tooth removal compared with people who don't use cannabis.

  Recruiting University of Michigan · Ann Arbor, Michigan · NCT07423195

• Brain‑wave and pain‑signal monitoring during anesthesia for ERCP to map opioid and sedative effects

  This trial will test whether continuous brain‑wave (EEG/PSI) and heart‑rate variability (ANI) monitoring during targeted infusions of opioids and sedatives can show how those drugs interact in people having ERCP under general anesthesia.

  Recruiting China Medical University Hospital · Miaoli · NCT07211828

• How common pain is in adults on mechanical ventilators in intensive care units

  The researchers will measure how often adults on invasive mechanical ventilation in ICUs experience pain and which clinical factors are linked to it.

  Recruiting at 4 sites Centro Universitário Augusto Motta · Rio de Janeiro, Rio de Janeiro and 3 other locations · NCT07182851

• No continuous sedation versus daily sedation interruption for ventilated COPD patients

  This compares no continuous sedation to daily sedation breaks to see which approach gives more ventilator-free days for adults with COPD on a breathing machine.

  Recruiting Benha University · Banhā, Qalyubia Governorate · NCT07146698

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.