Retrospective Analysis of the Safety and Efficacy of Sugammadex Versus Neostigmine for the Reversal of Neuromuscular Blockade in Children

Abstract

BACKGROUND: Sugammadex, with its novel mechanism of action of encapsulation and noncompetitive binding of aminosteroid neuromuscular-blocking agents (rocuronium and vecuronium), may offer distinct advantage to pediatric patients where residual neuromuscular blockade may be poorly tolerated. Data describing its use in the pediatric population are limited, and no large-scale studies are available evaluating the occurrence of adverse event across the full spectrum of ages. We sought to measure the occurrence of adverse events, assess the severity and clinical significance of the events, and quantify a surrogate measure of efficacy of sugammadex compared to neostigmine in a large population and in the full age range of children. METHODS: Beginning in September 2016 through initiation of data collection, we identified from our data warehouse that all patients were treated with sugammadex for reversal of neuromuscular blockade, from birth through adolescence, and retrospectively matched, by case type and age group, to historical neostigmine-treated controls. From subsequent chart review, we quantified occurrence of adverse events and administration of medications to treat adverse events. All cases in the originally identified cohort treated with epinephrine after administration of sugammadex underwent chart review to elicit the cause, in the event that an infrequently occurring event was not captured after the case-matching process. “End-Interval Time,” the time from administration of reversal agent to time out of the procedure room, was measured as an indirect assessment of efficacy. RESULTS: Fewer cases of bradycardia were observed in the sugammadex group compared to the neostigmine group in the overall cohort (P < .001) and in the subgroups of older children (P < .001) and adolescents (P < .001). End-interval time, the time measured from administration of neuromuscular blockade (NMB) reversal agent to time out of the operating room, was significantly shorter in sugammadex-treated groups in the overall cohort (mean difference, 2.8; 95% CI, 1.85–3.77; P < .001) and all age groups except for first year (31 days through 12 months). This observation was most pronounced in the neonatal subgroup (mean difference, 11.94 minutes; 95% CI, 4.79–19.1; P < .001). No other adverse events measured were found to be different between treatment groups. CONCLUSIONS: This study provides data supporting the safe and effective use of sugammadex for reversal of neuromuscular blockade throughout the entire range of ages in the pediatric population. Within age groups, sugammadex demonstrates faster completion of operation compared with neostigmine, with the greatest difference observed in the neonatal population.

Effect of sugammadex on postoperative pulmonary complications in patients with respiratory dysfunction after laparoscopic gastric or intestinal surgery: A retrospective study

“…This implies that NMB has a sedative effect by decreasing afferent input and subsequent stimulation of brain arousal centers [19][20]. Tracheal extubation time was de ned as the time between study drug administration to extubation, which was much shorter in the sugammadex group, as shown in a previous study [21], including in the elderly or pediatric population [22][23], because of a different mechanism than neostigmine by directly binding and rapidly inactivating steroidal neuromuscular blockers [24].…”

Sugammadex: Applications in Pediatric Critical Care

“…The previously referenced article of Gaver et al included only 18 neonates in the retrospective cohort of 968 pediatric patients who had received sugammadex. 34 Despite the limited number of neonates, the difference in the end-interval time (administration of reversal agent to OR exit time) between patients receiving sugammadex and those receiving neostigmine was greatest in the neonatal group as patients receiving sugammadex left the OR on an average of 11.94 minutes faster. No adverse effects and no difficulties with reversal of neuromuscular blockade were noted in neonates.…”

“…Other large, open label series, and retrospective reviews have reported the successful use of sugammadex to reverse perioperative neuromuscular blockade in various clinical scenarios in the pediatric-aged patient. [32][33][34][35] The first of these, published in the Russian literature, outlined the use of sugammadex in a cohort of 42 pediatric patients (2-17 years of age) undergoing surgery for oncologic conditions. 32 Retrospective experience has also demonstrated the efficacy of sugammadex as a component of a "fast track" anesthesia protocol to reverse neuromuscular blockade in a cohort of 14 pediatric patients following surgery for congenital heart disease using cardiopulmonary bypass.…”

“…Gaver et al retrospectively reviewed their experience with sugammadex and provided outcome data using a case-matched study design with patients who had received neostigmine. 34 The study cohort included 1,946 patients who received sugammadex. In patients receiving sugammadex, there was a decreased incidence of bradycardia in the overall cohort and in the subgroups of older children and adolescents.…”

Sugammadex Neuromuscular Blockade Reversal Associated With Lower Postoperative Arterial Carbon Dioxide Levels After Congenital Cardiac Surgery

“…In the pediatric population, evidence showed a more rapid reversal to a train-of-four of 0.9 with sugammadex compared with neostigmine without significant adverse events. [11][12][13][14][15][16] The rapid reversal of NMB achieved by sugammadex makes it an attractive alternative to neostigmine. However, there is a lack of published data regarding more functional endpoints, such as adequate ventilation, comparing the 2 medications.…”