Evaluation of the Efficacy and Safety of a Combined Dexmedetomidine-Ketamine Sedation Regimen for Pediatric Cardiac Catheterization at Vietnam National Children's Hospital

What this Trial Is About

This research aims to compare the safety and effectiveness of two sedation methods used during pediatric cardiac catheterization procedures. It focuses on whether a combined spontaneous sedation regimen of dexmedetomidine and ketamine (called KETADEX) works as well and is as safe as the traditional general anesthesia approach in children under 18 years undergoing these procedures. The study is observational and seeks to answer if KETADEX is not worse than general anesthesia in these respects. Participants receive either the KETADEX sedation, which allows natural breathing during the procedure using dexmedetomidine and ketamine, or the general anesthesia regimen that involves mechanical ventilation. The research team observes the cardiac catheterization and collects data on sedation effectiveness and any safety concerns. Two groups of pediatric patients are compared: those undergoing KETADEX sedation and those receiving general anesthesia. Throughout the catheterization procedure, researchers monitor sedation levels using the Ramsay Sedation Scale and record any adverse events related to breathing, heart function, or neurological status during recovery. They also gather safety information from the start of sedation until recovery ends, up to three hours after the procedure. This monitoring helps determine how well each sedation method performs and ensures participant safety during and after their cardiac catheterization.

Efficacy and Safety of a Combined Dexmedetomidine-Ketamine Sedation Regimen for Pediatric Cardiac Catheterization