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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 early 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. 15 minutes after rocuronium administration, 2 or 4 or 8mg/kg of sugammadex sodium or conventional neuromuscular reversal agent is administered according to randomization table.
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.
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 15 minutes after rocuronium administration |
|
| Sugammadex 4mg | Experimental | Administer 4mg/kg of sugammadex 15 minutes after rocuronium administration |
|
| Sugammadex 8mg | Experimental | Administer 8mg/kg of sugammadex 15 minutes after rocuronium administration |
|
| Conventional reversal | Active Comparator | Administer conventional neuromuscular reversal agent (0.02mg/kg of atropine and 0.03mg/kg of neostigmine) 15 minutes after rocuronium administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex Injection 2mg/kg | Drug | Intravenous injection of 2mg/kg of sugammadex sodium 15 minutes after rocuronium administration |
|
| 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: All of below
Exclusion Criteria: Any of below
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Sugammadex 2mg | Administer 2mg/kg of sugammadex 15 minutes after rocuronium administration Sugammadex Injection 2mg/kg: Intravenous injection of 2mg/kg of sugammadex sodium 15 minutes after rocuronium administration |
| FG001 | Sugammadex 4mg | Administer 4mg/kg of sugammadex 15 minutes after rocuronium administration Sugammadex Injection 4mg/kg: Intravenous injection of 4mg/kg of sugammadex sodium 15 minutes after rocuronium administration |
| FG002 | Sugammadex 8mg | Administer 8mg/kg of sugammadex 15 minutes after rocuronium administration Sugammadex Injection 8mg/kg: Intravenous injection of 8mg/kg of sugammadex sodium 15 minutes after rocuronium administration |
| FG003 | Conventional Reversal | Administer conventional neuromuscular reversal agent (0.02mg/kg of atropine and 0.03mg/kg of neostigmine) 15 minutes after rocuronium administration Neuromuscular reversal agent injection: Intravenous injection of 0.02mg/kg of atropine and 0.03mg/kg of neostigmine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sugammadex 2mg | Administer 2mg/kg of sugammadex 15 minutes after rocuronium administration Sugammadex Injection 2mg/kg: Intravenous injection of 2mg/kg of sugammadex sodium 15 minutes after rocuronium administration |
| BG001 | Sugammadex 4mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Minutes | up to 30 minutes to 1 hour |
|
From the start of anesthesia to 24 hours after the end of surgery.
No mortality, serious adverse event, adverse event related to study drug were observed during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sugammadex 2mg | Administer 2mg/kg of sugammadex 15 minutes after rocuronium administration Sugammadex Injection 2mg/kg: Intravenous injection of 2mg/kg of sugammadex sodium 15 minutes after rocuronium administration |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sang-Hwan Ji | Seoul National University Hospital | +82-2-2072-3661 | taepoongshin@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 19, 2019 | Oct 20, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D001285 | Atropine |
| D009388 | Neostigmine |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| Sugammadex Injection 4mg/kg | Drug | Intravenous injection of 4mg/kg of sugammadex sodium 15 minutes after rocuronium administration |
|
|
| Sugammadex Injection 8mg/kg | Drug | Intravenous injection of 8mg/kg of sugammadex sodium 15 minutes after rocuronium administration |
|
|
| 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. |
Administer 4mg/kg of sugammadex 15 minutes after rocuronium administration Sugammadex Injection 4mg/kg: Intravenous injection of 4mg/kg of sugammadex sodium 15 minutes after rocuronium administration |
| BG002 | Sugammadex 8mg | Administer 8mg/kg of sugammadex 15 minutes after rocuronium administration Sugammadex Injection 8mg/kg: Intravenous injection of 8mg/kg of sugammadex sodium 15 minutes after rocuronium administration |
| BG003 | Conventional Reversal | Administer conventional neuromuscular reversal agent (0.02mg/kg of atropine and 0.03mg/kg of neostigmine) 15 minutes after rocuronium administration Neuromuscular reversal agent injection: Intravenous injection of 0.02mg/kg of atropine and 0.03mg/kg of neostigmine |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Type of surgery | Count of Participants | Participants |
|
| OG002 | Sugammadex 8mg | Administer 8mg/kg of sugammadex 15 minutes after rocuronium administration Sugammadex Injection 8mg/kg: Intravenous injection of 8mg/kg of sugammadex sodium 15 minutes after rocuronium administration |
| OG003 | Conventional Reversal | Administer conventional neuromuscular reversal agent (0.02mg/kg of atropine and 0.03mg/kg of neostigmine) 15 minutes after rocuronium administration Neuromuscular reversal agent injection: Intravenous injection of 0.02mg/kg of atropine and 0.03mg/kg of neostigmine |
|
|
| Secondary | Plasma Concentrations | Plasma concentrations of rocuronium and sugammadex sodium | Cmax of sugammadex and rocuronium | Posted | Mean | Standard Deviation | mcg/mL | From anesthetic induction to 480 minutes after sugammadex administration |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Sugammadex 4mg | Administer 4mg/kg of sugammadex 15 minutes after rocuronium administration Sugammadex Injection 4mg/kg: Intravenous injection of 4mg/kg of sugammadex sodium 15 minutes after rocuronium administration | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Sugammadex 8mg | Administer 8mg/kg of sugammadex 15 minutes after rocuronium administration Sugammadex Injection 8mg/kg: Intravenous injection of 8mg/kg of sugammadex sodium 15 minutes after rocuronium administration | 0 | 10 | 0 | 10 | 0 | 10 |
| EG003 | Conventional Reversal | Administer conventional neuromuscular reversal agent (0.02mg/kg of atropine and 0.03mg/kg of neostigmine) 15 minutes after rocuronium administration Neuromuscular reversal agent injection: Intravenous injection of 0.02mg/kg of atropine and 0.03mg/kg of neostigmine | 0 | 10 | 0 | 10 | 0 | 10 |
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| 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 |
|
| Rocuronium |
|
|