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Sugammadex for Reversal of Neuromuscular Blockade in Neonates and Infants Less than 2 Years Old: Results from a Phase
Edith Mensah-Osman1, Yuki Mukai1, Aobo Wang1
1Merck & Co., Inc., Rahway, New Jersey.
Insights
Sugammadex effectively and safely reverses neuromuscular blockade in children under two years old. It demonstrated faster recovery times for moderate blockade compared to neostigmine and rapid reversal for deep blockade.
Area of Science:
- Anesthesiology
- Pediatric Pharmacology
- Clinical Trial Research
Background:
- Sugammadex is established for neuromuscular blockade reversal in adults and older children.
- Limited data exists on sugammadex efficacy and safety in pediatric patients under two years of age.
Purpose of the Study:
- To evaluate the efficacy and tolerability of sugammadex in pediatric patients younger than two years.
- To compare sugammadex reversal of moderate neuromuscular blockade against neostigmine in this age group.
Main Methods:
- A Phase IV, randomized, multicenter clinical trial involving infants and children aged birth to under two years.
- Participants received sugammadex (2 mg/kg or 4 mg/kg) or neostigmine for neuromuscular blockade reversal.
- Primary endpoint was time to neuromuscular recovery (TTNMR); pharmacokinetic assessments informed dosing.
Main Results:
- Sugammadex 2 mg/kg reversed moderate neuromuscular blockade faster than neostigmine (1.4 min vs 4.4 min).
- Sugammadex 4 mg/kg provided rapid reversal of deep neuromuscular blockade (median 1.1 min).
- Adverse event rates were similar between sugammadex and neostigmine; no serious adverse events were reported.
Conclusions:
- Sugammadex is effective for reversing moderate and deep neuromuscular blockade in children under two years.
- Sugammadex demonstrates a favorable safety profile and faster recovery times compared to neostigmine in this pediatric population.
Background:
Sugammadex is well tolerated and effective for reversing neuromuscular blockade (NMB) in adults and children as young as 2 yr old. There is little information on its use in younger children. The aim of this study was to evaluate the efficacy and tolerability of sugammadex in children under 2 yr of age.
Methods:
This was a phase IV, randomized, parallel-group, multicenter clinical trial of sugammadex in participants aged birth to less than 2 yr (NCT03909165). Part A was open label and included pharmacokinetic assessments to determine whether sugammadex dose adjustment for part B was necessary based on age. Part B was double-blind and evaluated doses of 2 and 4 mg/kg sugammadex. Participants were randomized to (1) moderate NMB and reversal with 2 mg/kg sugammadex; (2) moderate NMB and reversal with neostigmine + glycopyrrolate or atropine (hereafter, called neostigmine); or (3) deep NMB and reversal with 4 mg/kg sugammadex. The primary efficacy endpoint was time to neuromuscular recovery (TTNMR). The primary efficacy hypothesis was that 2 mg/kg sugammadex would be superior to neostigmine for the reversal of moderate NMB as measured by TTNMR in part B.
Results:
A total of 138 participants aged 1 to 720 days were treated in parts A and B (2 mg/kg sugammadex, n = 44; 4 mg/kg sugammadex, n = 63; and neostigmine, n = 31). Based on pharmacokinetic assessments in part A, no dose adjustments for age were needed. In part B, TTNMR for reversal of moderate NMB was faster with 2 mg/kg sugammadex than neostigmine (median of 1.4 min vs. 4.4 min; hazard ratio, 2.40; 95% CI, 1.37 to 4.18; P = 0.0002). A 4-mg/kg dose of sugammadex achieved rapid TTNMR for reversal of deep NMB with a median of 1.1 min (parts A and B). The percentage of participants with one or more adverse events (parts A and B) was similar for sugammadex and neostigmine. No deaths, drug-related serious adverse events, or hypersensitivity or anaphylaxis events were reported.
Conclusions:
In children less than 2 yr old, 2 mg/kg sugammadex reversed moderate NMB faster than neostigmine, and 4 mg/kg sugammadex rapidly reversed deep NMB. Sugammadex doses of 2 and 4 mg/kg were well tolerated.
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