Sugammadex for reversal of neuromuscular blockade in pediatric patients: Results from a phase IV randomized study
- Study type: Randomised double blinded study in paediatric patients (>2years old).
- Methods: Sugammadex vs. neostigmine for reversal of moderate-deep neuromuscular blockade (NMB) from rocuronium/vecuronium. Primary endpoint train of four (TOF) ³9. 288 patients. Adequately powered.
- Drug company funded. Some authors employed by drug company.
- Findings: Time to TOF ³9:
- 6 min for 2 mg/kg sugammadex
- 0 min for 4 mg/kg sugammadex
- 5 min for neostigmine
- Nil significant adverse effects reported including hypersensitivity. Of note, clinically relevant bradycardia was recorded in 5.9% in the neostigmine group vs. £2% in the sugammadex groups.
Take Home Message / Commentary
Adds to growing evidence base for efficacy and safety of sugammadex in children.
- Clinical relevance of 6 min time difference. Did not measure more clinically relevant emergence parameters (e.g., respiratory embarrassment, PONV)
Reviewed by Dr. Philip Cheung