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.

Unanswered questions:

  • 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