drugset / Trial / NCT04347486
Pharmacokinetic-pharmacodynamic Analysis of Sugammadex for Conventional Reversal in Children
Phase 2
Completed
32 enrolled
Seoul National University Hospital
Ministry of Food and Drug Safety, Korea · collab
RandomizedParallel-groupOpen-labelSupportive care
Summary
This study administers sugammadex sodium to pediatric patients under general anesthesia with rocuronium. Pharmacokinetic and pharmacodynamic analysis are performed based on plasma concentration of sugammadex sodium and monitoring of neuromuscular blockade.
Timeline
- Start
- 2020-04-29
- Primary completion
- 2021-12-07
- Completion
- 2021-12-07
Publications
- Background Gijsenbergh F, Ramael S, Houwing N, van Iersel T. First human exposure of Org 25969, a novel agent to reverse the action of rocuronium bromide. Anesthesiology. 2005 Oct;103(4):695-703. doi: 10.1097/00000542-200510000-00007.
- Background Sorgenfrei IF, Norrild K, Larsen PB, Stensballe J, Ostergaard D, Prins ME, Viby-Mogensen J. Reversal of rocuronium-induced neuromuscular block by the selective relaxant binding agent sugammadex: a dose-finding and safety study. Anesthesiology. 2006 Apr;104(4):667-74. doi: 10.1097/00000542-200604000-00009.
- Background Sparr HJ, Vermeyen KM, Beaufort AM, Rietbergen H, Proost JH, Saldien V, Velik-Salchner C, Wierda JM. Early reversal of profound rocuronium-induced neuromuscular blockade by sugammadex in a randomized multicenter study: efficacy, safety, and pharmacokinetics. Anesthesiology. 2007 May;106(5):935-43. doi: 10.1097/01.anes.0000265152.78943.74.
- Background Ploeger BA, Smeets J, Strougo A, Drenth HJ, Ruigt G, Houwing N, Danhof M. Pharmacokinetic-pharmacodynamic model for the reversal of neuromuscular blockade by sugammadex. Anesthesiology. 2009 Jan;110(1):95-105. doi: 10.1097/ALN.0b013e318190bc32.
- Background Won YJ, Lim BG, Lee DK, Kim H, Kong MH, Lee IO. Sugammadex for reversal of rocuronium-induced neuromuscular blockade in pediatric patients: A systematic review and meta-analysis. Medicine (Baltimore). 2016 Aug;95(34):e4678. doi: 10.1097/MD.0000000000004678.
- Ji SH, Huh KY, Oh J, Jeong HJ, Jang YE, Kim EH, Lee JH, Kim JT, Kim HS. Conventional reversal of rocuronium-induced neuromuscular blockade by sugammadex in Korean children: pharmacokinetics, efficacy, and safety analyses. Front Pharmacol. 2023 Apr 13;14:1127932. doi: 10.3389/fphar.2023.1127932. eCollection 2023.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Atropine | Other / unclassified | 0.02 mg/kg | Intravenous |
| Comparator | Neostigmine | Other / unclassified | 0.03 mg/kg | Intravenous |
| Subject | Sugammadex | Other / unclassified | 2 mg/kg | Intravenous |
| Subject | Sugammadex | Other / unclassified | 4 mg/kg | Intravenous |
| Subject | Sugammadex | Other / unclassified | 8 mg/kg | Intravenous |
Indications
No indication recorded.