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This is a prospective dose-finding study of sugammadex for conventional reversal of rocuronium-induced neuromuscular blockade in children under two years of age. This study will explore 50% effective dose and 95% effective dose of sugammadex for reversal of neuromuscular blockade in less than two minutes under biased coin up-and-down method.
The investigators are planning to enroll 33 patients to obtain data. The starting dose of sugammadex will be 0.5mg/kg. When the dose for a patient was not effective, the dose for next patient will be increased by 0.5mg/kg. When the dose was effective, the dose for next patient will be decreased by 0.5mg/kg or maintained, with a 1:1 of allocation ratio.
The investigators will also monitor incidence of any adverse events including residual blockade to evaluate safety of sugammadex in children younger than two years old.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | Sequential determination of dose according to previous participant's result and by chance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex | Drug | The starting dose of sugammadex will be 0.5mg/kg. When the dose for a patient was not effective, the dose for next patient will be increased by 0.5mg/kg. When the dose was effective, the dose for next patient will be decreased by 0.5mg/kg or maintained, with a 1:1 of allocation ratio. |
| Measure | Description | Time Frame |
|---|---|---|
| 50% effective dose | Dose of sugammadex that can reverse neuromuscular blockade in 50% of patients. | From start of sugammadex administration to 2 minute after end of administration |
| 95% effective dose | Dose of sugammadex that can reverse neuromuscular blockade in 95% of patients. | From start of sugammadex administration to 2 minute after end of administration |
| Measure | Description | Time Frame |
|---|---|---|
| TOF result | Response to train-of-four stimulation after administration of sugammadex | From start of sugammadex administration to 2 minute after end of administration |
| Residual blockade | Incidence of recurarization in the postanesthesia care unit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sang-Hwan Ji, M.D., Ph.D. | Contact | +82-2-2072-3661 | jsh1@snu.ac.kr | |
| Jung-Bin Park, M.D., Ph.D. | Contact | +82-2-2072-3661 | jb4001@snu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Sang-Hwan Ji, M.D., Ph.D. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | 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 | Term |
|---|---|
| D000077122 | Sugammadex |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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Up-and-down dose finding method using biased coin design
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|
|
| From start of sugammadex administration to 24 hours after end of administration |
| Blood pressure | Noninvasive blood pressure after sugammadex administration measured in the operating room and postanesthesia care unit | From start of sugammadex administration to discharge from postanesthesia care unit (less than 3 hours) |
| Pulse oximetry | Pulse oximetry after sugammadex administration measured in the operating room and postanesthesia care unit | From start of sugammadex administration to discharge from postanesthesia care unit (less than 3 hours) |
| 19194156 | Background | Plaud B, Meretoja O, Hofmockel R, Raft J, Stoddart PA, van Kuijk JH, Hermens Y, Mirakhur RK. Reversal of rocuronium-induced neuromuscular blockade with sugammadex in pediatric and adult surgical patients. Anesthesiology. 2009 Feb;110(2):284-94. doi: 10.1097/ALN.0b013e318194caaa. |
| 16353925 | Background | Meibohm B, Laer S, Panetta JC, Barrett JS. Population pharmacokinetic studies in pediatrics: issues in design and analysis. AAPS J. 2005 Oct 5;7(2):E475-87. doi: 10.1208/aapsj070248. |
| 22575569 | Background | Olutoye OA, Yu X, Govindan K, Tjia IM, East DL, Spearman R, Garcia PJ, Coulter-Nava C, Needham J, Abrams S, Kozinetz CA, Andropoulos DB, Watcha MF. The effect of obesity on the ED(95) of propofol for loss of consciousness in children and adolescents. Anesth Analg. 2012 Jul;115(1):147-53. doi: 10.1213/ANE.0b013e318256858f. Epub 2012 May 10. |
| 11890313 | Background | Stylianou M, Flournoy N. Dose finding using the biased coin up-and-down design and isotonic regression. Biometrics. 2002 Mar;58(1):171-7. doi: 10.1111/j.0006-341x.2002.00171.x. |
| D003912 |
| Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |