Heart rate changes following the administration of sugammadex in children: a prospective, observational study.

ABSTRACT

INTRODUCTION: Sugammadex is a novel agent to reverse steroidal neuromuscular blocking agents (NMBA) with potential clinical advantages over acetylcholinesterase inhibitors such as neostigmine. However, rare instances of bradycardia were reported during its initial clinical trials. To better define this issue, its incidence and mitigating factors, we prospectively evaluated heart rate changes after sugammadex administration in pediatric-aged patients. METHODS: Patients less than 18 years of age who were to receive sugammadex were included. After sugammadex administration, heart rate (HR) was recorded every minute for 15 min and then every 5 min for the next 15 min or until the patient was transferred from the operating room. Bradycardia was defined as HR below the 5th percentile for age. RESULTS: The study cohort included 221 children. Bradycardia was noted in 18 cases (8%; 95% confidence interval 5%, 13%), occurring at a median of 2 min (IQR 1, 6) after sugammadex administration. Among patients developing bradycardia, 7 of 18 (38%) had comorbid cardiac conditions (congenital heart disease). No patient required treatment for bradycardia and no clinically significant blood pressure (BP) changes were noted. On bivariate analysis, initial sugammadex dose was not associated with bradycardia onset. In multivariable analysis, cardiac comorbid conditions and male gender were associated with an increased incidence of bradycardia. CONCLUSIONS: The incidence of bradycardia following the administration of sugammadex is low, is not associated with BP changes or other clinically significant effects, and did not require treatment. A higher incidence of bradycardia was noted in patients with cardiac comorbid conditions.