The synergistic effect of dexmedetomidine on propofol for paediatric deep sedation: A randomised trial.

BACKGROUND: Propofol and dexmedetomidine are used separately, and sometimes together, for paediatric deep sedation. Although their combination has been described in adults, the effect of dexmedetomidine as a potential synergist in children has not been studied before. OBJECTIVES: The primary objective was to compare the propofol requirements of children who receive propofol alone with those who receive it in combination with dexmedetomidine for deep sedation for upper and lower endoscopic gastrointestinal procedures. DESIGN: This was a prospective, open-label, randomised study comparing patients who received propofol alone (group P) with those who received dexmedetomidine and propofol (group DP). The depth of sedation was titrated to a target bispectral (BIS) index. SETTING: A Gastroenterology Procedure Unit at a single, tertiary care academic medical centre from April 2018 until December 2019. PATIENTS: Eligible patients were scheduled for upper endoscopy, lower endoscopy or both. A total of 39 patients were enrolled (20 DP) and (19 P). INTERVENTIONS: Patients in Group DP received dexmedetomidine 0.5 µg kg-1 administered over 1 min followed by an infusion of 0.15 µg kg-1 h-1. In both groups, intravenous propofol was given in bolus increments titrated to a BIS index of 40 to 50 and then a continuous infusion of propofol to maintain BIS at 40 to 50. MAIN OUTCOME MEASURES: The primary outcome measure was propofol requirement in each group. Secondary outcome measures were time to achieve the targeted sedation depth, time to achieve an Aldrete recovery score of 9, duration of sedation, mean BIS values, adverse events, 'PAED' scores and time to discharge from the postanaesthesia care unit (PACU). RESULTS: The median (range) total dose of propofol was 0.23 (0.10 to 0.50) mg kg-1 min-1 in group DP and 0.40 (0.20 to 0.50) mg kg-1 min-1 in group P (P = 0.0004). Time of discharge from the PACU was 60 (20 to 121) min in group DP and 63 (46 to 91) min in group P (P = 0.0409). CONCLUSION: The combination of dexmedetomidine and propofol for paediatric procedural sedation achieved a significant reduction in median propofol dose and a slightly shorter median time to discharge from PACU. Large-scale studies may determine whether this reduction decreases the risk of significant adverse events. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02952222.