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Compares treatment options for Sedation and Analgesia
Official title a Comparive Study of Ketamine-Propofol Versus Dexmedetomidine-Propofol Sedation in Pediatric Patients Undergoing Cardiac Catheterization for Device Closure of Simple Left-to-right Shunts
ClinicalTrials.gov ID: NCT07669012
What this study is testing
What is Ketamine + propofol?
Ketamine + propofol is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sedation and analgesia.
Also referred to as Sedation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims To compare the safety and efficacy of ketamine-propofol versus dexmedetomidine-propofol sedation in pediatric patients undergoing cardiac catheterization for device closure of simple left-to-right shunts
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 12
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Cairo, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cairo, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.