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| Name | Class |
|---|---|
| Ministry of Food and Drug Safety, Korea | OTHER_GOV |
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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.
This study enrolls pediatric patients undergoing surgery under general anesthesia with need for reversal of neuromuscular blockade, aged between 2 and 18 years old.
After routine anesthetic induction with 1% propofol and 0.6mg/kg of rocuronium, maintenance of anesthesia with total intravenous anesthesia is commenced. For neuromuscular monitoring, train-of-four (TOF) count and T4/T1 ratio are monitored, with recording of the time to recovery of the T4/T1 ratio to 0.7, 0.8 and 0.9.
On reappearance of T2 after rocuronium administration , 2 or 4 or 8mg/kg of sugammadex sodium or conventional neuromuscular reversal agent is administered according to randomization table.
For pharmacokinetic analysis, patient blood sample is obtained before / 2 min after rocuronium administration, before / 2min / 5min / 15min / 60min / 120min / 240min / 480min after sugammadex administration. Plasma concentration of rocuronium and sugammadex sodium are analyzed via high-performance liquid chromatography with mass spectrometric detection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugammadex 2mg | Experimental | Administer 2mg/kg of sugammadex on reappearance of T2 by Train-of-Four stimulation |
|
| Sugammadex 4mg | Experimental | Administer 4mg/kg of sugammadex on reappearance of T2 by Train-of-Four stimulation |
|
| Sugammadex 8mg | Experimental | Administer 8mg/kg of sugammadex on reappearance of T2 by Train-of-Four stimulation |
|
| Conventional reversal | Active Comparator | Administer conventional neuromuscular reversal agent (0.02mg/kg of atropine and 0.03mg/kg of neostigmine) on reappearance of T2 by Train-of-Four stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex Injection 2mg/kg | Drug | Intravenous injection of 2mg/kg of sugammadex sodium on reappearance of T2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neuromuscular recovery | Time to recovery of train-of-four T4/T1 ratio to 90% after sugammadex sodium or neuromuscular reversal agent administration up to 30 minutes to 1 hour. | up to 30 minutes to 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations | Plasma concentrations of rocuronium and sugammadex sodium | From anesthetic induction to 480 minutes after sugammadex administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hee-Soo Kim, M.D., Ph.D. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SNUH | Seoul | Jongro Gu | 15710 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16192761 | 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. | |
| 16571960 | 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. |
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| Sugammadex Injection 4mg/kg | Drug | Intravenous injection of 4mg/kg of sugammadex sodium on reappearance of T2 |
|
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| Sugammadex Injection 8mg/kg | Drug | Intravenous injection of 8mg/kg of sugammadex sodium on reappearance of T2 |
|
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| Neuromuscular reversal agent injection | Drug | Intravenous injection of 0.02mg/kg of atropine and 0.03mg/kg of neostigmine |
|
|
| 17457124 | 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. |
| 19104176 | 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. |
| 27559972 | 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. |
| 37124204 | Derived | 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. |
| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D001285 | Atropine |
| D009388 | Neostigmine |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009861 | Onium Compounds |
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