Nasal and Intravenous Administration of Dexmedetomidine to Prevent the Emergence Agitation After the Vascular Interventional Surgery in Children: A Randomized, Double-blind, Controlled Study

Abstract Introduction : Dexmedetomidine reduces the incidences of postanesthetic restlessness and hemodynamic fluctuations in children within acceptable ranges. Dexmedetomidine nasal drop prior to the surgery reduces the EA after anesthesia. There are several studies that compare the effects of dexmedetomidine nasal drop and intravenous injection, in which they were administered prior to the induction of anesthesia.This double-blind, randomized, controlled study was performed to compare the effects of dexmedetomidine nasal drop and intravenous injection on postoperative emergence agitation (EA), sedation, and hemodynamics in pediatric patients prior to and post surgery. METHODS : We randomly divided 120 children, who were enrolled in this study, into the control, dexmedetomidine nasal, and dexmedetomidine intravenous injection groups. The dexmedetomidine dose for nasal use was 2 µg / kg, and that for intravenous injection was 0.8 µg / kg. The nasal dose and the intravenous injection were, respectively, administered 30 and 10 min prior to the surgery being culminated. The EA was recorded within 30 min in the post-anesthesia care unit (PACU) and within 3 h in the ward. The incidence of EA, Ramsay scores, heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP), and adverse events were recorded. RESULTS : In the PACU, the EA incidences in the nasal dose, intravenous injection, and control groups were 27.50%, 20.00%, and 52.50%, respectively. Statistical differences between the nasal and control groups ( p < 0.05, OR = 0.343, 95% CI [0.135–0.871]) and the intravenous and control groups ( p < 0.05, OR = 0.226, 95% CI [0.084–0.610]) were recorded. The EA incidence was not statistically different between the nasal and intravenous injection groups. The proportions of Propofol users were 52.50%, 27.50%, and 92.50% in the nasal spray, intravenous injection, and control groups, respectively. Statistically significant differences among the three groups ( p < 0.05) were observed. The EA incidences in the nasal drop, intravenous injection, and control groups in the ward were 20.00%, 17.50%, and 70.00%, respectively. Statistically significant difference between the nasal drop and control groups ( p < 0.05, OR = 0.107, 95% CI [0.038–0.300]) and the intravenous and control groups ( p < 0.05, OR = 0.091, 95% CI [0.032–0.262]) were found. There was no significant difference in EA incidence between the nasal drop and intravenous injection groups. CONCLUSION : Dexmedetomidine nasal and intravenous administrations have similar effects in reducing the EA incidence within 30 min in the PACU and 3 h in the ward. In the PACU the sedation depth in the intravenous injection group was greater than that in the nasal drop group and within the 3 h in the ward, the depth of sedation was the same for both administration routes. The intravenous injection affects the HR more than the nasal drop within 5 min of administration. Thus, dexmedetomidine nasal drop prior to the culmination of the surgery is more suitable for PACU and ward sedation to prevent EA. Trial registration : The registration number ,ChiCTR1900021325(http://www.chictr.org.cn/index.aspx),The date of registration,02/15/2019.