Pediatric anesthesia & critical care
Sugammadex for Reversal of Neuromuscular Blockade in Neonates and Infants Less than 2 Years Old: Results from a Phase IV Randomized Clinical Trial
Authors' conclusion
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.
Study context
- Population
- Children aged birth to less than 2 yrtreated in parts A and B
- Participants
- 138 children
- Comparison
- 2 mg/kg sugammadex vs Neostigmine
- 2 mg/kg sugammadexn = 44
- Neostigminen = 31reference
- 4 mg/kg sugammadexn = 63
- Primary endpoint
- Time to neuromuscular recovery (TTNMR); superiority of 2 mg/kg sugammadex vs neostigmine for moderate NMB in part B
Methodological detailsphase IV, parallel-group, multicentre, part A open label, part B double-blind
- Phase IV
- Parallel-group
- Multicentre
- Part A open label
- Part B double-blind
Primary result
TTNMR, reversal of moderate NMB (part B)
Hazard ratio
2.40
95% CI 1.37–4.18
P = 0.0002
By group
2 mg/kg sugammadex vs Neostigmine
HR 2.40 (95% CI 1.37–4.18); P = 0.0002
As reported in the abstract
Further findings
- Time to neuromuscular recovery (TTNMR), reversal of deep neuromuscular blockade (NMB) (parts A and B) — 4 mg/kg sugammadex
- median 1.1 min
Pharmacokinetics (part A)
- No dose adjustments for age needed
Deaths, drug-related serious adverse events, hypersensitivity or anaphylaxis
- None reported
- 0
Safety
≥1 adverse event (parts A and B)
- Similar for sugammadex and neostigmine
Original publication
Sugammadex for Reversal of Neuromuscular Blockade in Neonates and Infants Less than 2 Years Old: Results from a Phase IV Randomized Clinical Trial. Anesthesiology. Published 5 May 2025. doi:10.
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