Propofol/dexmedetomidine and propofol/ketamine combinations for anesthesia in pediatric patients undergoing transcatheter atrial septal defect closure: a prospective randomized study.

BACKGROUND: Children undergoing cardiac catheterization usually need general anesthesia or deep sedation.
OBJECTIVE: This study was performed to compare the effects of propofol/dexmedetomidine and propofol/ketamine combinations on recovery time and hemodynamic parameters in pediatric patients undergoing transcatheter atrial septal defect (ASD) closure.
METHODS: This was a prospective randomized study. Pediatric patients with ASD were randomly assigned into 2 groups to receive propofol/dexmedetomidine or propofol/ketamine. The dexmedetomidine group received an infusion over 10 minutes of dexmedetomidine 1 microg/kg and propofol 2.0 to 2.5 mg/kg bolus for induction, then an infusion of dexmedetomidine 0.5 microg/kg/h and propofol 4 to 6 mg/kg/h for maintenance. In the ketamine group, patients received the same dose of propofol and ketamine 1 mg/kg for induction and 0.5 mg/kg/h by infusion for maintenance. The procedure was performed using both fluoroscopy and transesophageal echocardiography. Hemodynamic data, respiratory rate, and oxygen saturation were recorded before and after induction, 1 and 5 minutes after intubation, every 10 minutes thereafter during the procedure, and after extubation by researchers blinded to the study drugs. Recovery time, the primary outcome, was evaluated by a modified Steward score; a score of >or=6 means that the patient is awake or responds to verbal stimuli, has purposeful motor activity, and coughs on command. The time to reach a modified Steward score of >or=6 was recorded. The secondary outcome was the effects on the hemodynamic variables. Creatine kinase muscle-brain subunit, myoglobin, cardiac troponin I, and brain natriuretic peptide were the biochemical variables measured. Patients were monitored for respiratory (changes in oxygen status) and hemodynamic adverse effects (heart rate changes, blood pressure changes) until the second hour in the intensive care unit after the operation was concluded.
RESULTS: Nine patients each were randomly assigned to propofol/dexmedetomidine and propofol/ketamine. The demographic and clinical parameters were not significantly different between groups. In the dexmedetomidine group, 5 of the patients were male, mean (SD) age was 12.5 (10.4) years, and mean weight was 40.8 (27.8) kg. In the ketamine group, 3 patients were male, mean age was 10.1 (4.5) years, and mean weight was 30.0 (15.2) kg. The recovery time was significantly longer in the ketamine group than in the dexmedetomidine group (10.5 [3.4] vs 5.7 [0.8] minutes; P = 0.01). Systolic and diastolic blood pressure values were not significantly different between groups in any study period. Heart rate values were significantly higher in the ketamine group at 5 minutes after intubation (106.6 vs 84.2 beats/min), 10 minutes (111.8 vs 87.4 beats/min) and 30 minutes (110.0 vs 89.6 beats/min) perioperatively, and after extubation (126.8 vs 92.2 beats/min) (all, P < 0.05). In the dexmedetomidine group, one patient experienced shivering and one reported nausea; in the ketamine group, one patient reported nausea. Neither respiratory depression nor severe hypotension (ie, >20% change over baseline or requiring intervention) was observed in any patient. One patient developed agitation in the ketamine group.
CONCLUSIONS: In this small study, both dexmedetomidine and ketamine in combination with propofol were well tolerated in these pediatric patients who required ASD closure. The recovery period was significantly shorter in the dexmedetomidine group.

RCT Entities:   Population Interventions Outcomes