14-05-2025
Adult Sugammadex Dosing Safe, Effective in Kids Aged < 2
Sugammadex doses of 2 and 4 mg/kg, recommended for adults and children aged 2 years or older, were safe and effective for reversing neuromuscular blockade (NMB) in neonates and infants younger than 2 years. The 2-mg/kg dose of sugammadex reversed moderate NMB faster than neostigmine plus glycopyrrolate or atropine (neostigmine), whereas the 4-mg/kg dose led to a rapid reversal of deep NMB.
METHODOLOGY:
Researchers conducted a phase 4, multicenter clinical trial (July 2019-September 2023) to assess the tolerability and efficacy of sugammadex in reversing NMB in children younger than 2 years.
Overall, 138 children (mean age, 164 days; 66.7% boys) received NMB induced by rocuronium or vecuronium for surgeries such as repair of a cleft lip or an inguinal hernia, and orchidopexy.
The first part of the trial was open label and involved pharmacokinetic assessments of 2- and 4-mg/kg doses of sugammadex to determine if dose adjustment was necessary based on age.
The second part was double blind, with patients randomly assigned to receive a 2-mg/kg dose of sugammadex for reversing moderate NMB (defined as return of second twitch), neostigmine for reversing moderate NMB, or a 4-mg/kg dose of sugammadex for reversing deep NMB (defined as a post-tetanic count of 1 or 2).
The primary efficacy endpoint was time to neuromuscular recovery.
TAKEAWAY:
Doses of sugammadex of 2 and 4 mg/kg were found appropriate for reversing moderate and deep NMB in children younger than 2 years, according to pharmacokinetic assessments performed in the first part of the trial.
In moderate NMB, time to neuromuscular recovery was significantly faster with the 2-mg/kg dose of sugammadex than with neostigmine (hazard ratio, 2.40; P = .0002).
= .0002). A rapid neuromuscular recovery for deep NMB was achieved over a median of 1.1 minutes with the 4-mg/kg dose of sugammadex.
Procedural pain and vomiting were the most frequently reported adverse events, with no significant differences observed between the sugammadex and neostigmine groups. No deaths or drug-related serious adverse events were reported with either doses of sugammadex.
IN PRACTICE:
'These results support the use of sugammadex doses of 2 mg/kg and 4 mg/kg, the same doses as recommended for children > 2 years old and adults, for reversing rocuronium- or vecuronium-induced moderate and deep NMB in the youngest pediatric population from birth to < 2 years of age,' the researchers reported.
SOURCE:
This study was led by Edith Mensah-Osman, MD, PhD, and Yuki Mukai, MD, from Merck & Co., Inc., Rahway, New Jersey. It was published online on May 5, 2025, in Anesthesiology .
LIMITATIONS:
The pharmacokinetic analyses in the first part of the trial involved a relatively small number of participants, particularly for the cohort of infants aged 1 month or younger. The study was not designed as a dose-ranging trial but rather to confirm established doses from older age groups. The potential influence of the total dose of NMB agents was not evaluated.
DISCLOSURES:
This study received funding from Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. Nine authors reported being employed by and owing stocks in the funding agency, and two authors reported receiving research grants from the same organization.
