Comparing Two Sedation Methods Using Ketamine-Propofol Versus Dexmedetomidine-Propofol in Children Aged 2 to 12 Undergoing Cardiac Catheterization for Simple Heart Shunts

What this Trial Is About

Researchers are evaluating the safety and effectiveness of two sedation combinations, ketamine-propofol and dexmedetomidine-propofol, in children aged 2 to 12 undergoing cardiac catheterization to close simple left-to-right heart shunts. This phase 1 clinical trial focuses on pediatric patients having elective transcatheter device closure procedures for defects such as atrial septal defect, ventricular septal defect, or patent ductus arteriosus. Participants will be randomly assigned to receive one of two sedation regimens during their procedure. One group will receive an initial IV bolus of ketamine followed by a propofol infusion, while the other group will receive a dexmedetomidine loading dose and propofol infusion. Both treatments allow additional propofol doses if sedation is inadequate. The study monitors sedation during the procedure guided by echocardiography. Throughout the trial, children will be closely monitored for respiratory complications, heart rate, blood pressure, sedation quality, and recovery time within two hours after sedation. Safety and sedation levels will be assessed continuously to compare the two sedation methods. Participation involves the procedure and related assessments, with follow-up monitoring conducted during and shortly after the intervention.

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