Adult Sugammadex Dosing Safe, Effective in Kids Aged < 2

TOPLINE:

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).
• 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.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.