Comparison of Methylprednisolone and Dexamethasone in Their Interaction With Sugammadex in Pediatric Patients: A Randomized Controlled Trial.
TL;DR
Methylprednisolone was associated with longer sugammadex-mediated reversal and extubation time than dexamethasone and control, while postoperative pain, nausea scores, and adverse event rates were comparable between the groups.
Abstract
Background
Sugammadex may interact with steroidal compounds; however, comparative clinical data on different peri-operative corticosteroids in children are limited. This randomized controlled trial primarily aimed to compare the effect of methylprednisolone and dexamethasone, administered at clinically equivalent glucocorticoid doses, on sugammadex-mediated reversal time of rocuronium-induced neuromuscular block in children. Secondary aims were to compare extubation time, postoperative nausea, pain, and adverse events related to upper airway oedema between groups.
Methods
Sixty children undergoing adenotonsillar surgery were randomized 1:1:1 to receive methylprednisolone 1 mg kg-1, dexamethasone 0.2 mg kg-1, or no corticosteroid (control). Neuromuscular monitoring followed the Good Clinical Research Practice in pharmacodynamic studies of neuromuscular blocking agents standards. The primary endpoint was the rocuronium reversal time: interval from the sugammadex bolus at train of four count = 2 to a normalized train of four ratio of 0.9. Extubation time (interval from the sugammadex bolus at a train of four count = 2 until tracheal extubation); severity scores for postoperative pain and nausea; and frequency of adverse events related to upper airway oedema were the secondary endpoints. Between-group comparisons used one-way ANOVA or Welch's ANOVA for normally distributed data and the Kruskal-Wallis test for non-normally distributed data, with Bonferroni-corrected post hoc pairwise comparisons.
Results
The study population had a mean ± SD age, weight, and height of 7.9 ± 2.0 years, 30.0 ± 9.3 kg, and 129.0 ± 11.0 cm, respectively, with comparable demographic and baseline profiles across groups. Reversal time was longer with methylprednisolone (mean ± SD: 82.8 ± 16.1 s) than with dexamethasone (63.4 ± 13.4 s) and control (56.1 ± 13.7 s) (p < 0.001). Extubation time showed a similar pattern. Postoperative nausea-vomiting, pain scores, and the overall incidence of adverse events did not differ significantly between groups.
Conclusions
At clinically equivalent glucocorticoid doses, methylprednisolone was associated with longer sugammadex-mediated reversal and extubation time than dexamethasone and control, while postoperative pain, nausea scores, and adverse event rates were comparable between the groups. These findings indicate that the corticosteroid selected for peri-operative use may influence the efficacy of sugammadex-mediated reversal in children. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT07175623.