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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03943888
Recruitment Status Completed
First Posted May 9, 2019
Last update posted April 14, 2020
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.
|Experimental: Sugammadex 2mg
Administer 2mg/kg of sugammadex 15 minutes after rocuronium administration
Drug: Sugammadex Injection 2mg/kg
Intravenous injection of 2mg/kg of sugammadex sodium 15 minutes after rocuronium administration
|Experimental: Sugammadex 4mg
Administer 4mg/kg of sugammadex 15 minutes after rocuronium administration
Drug: Sugammadex Injection 4mg/kg
Intravenous injection of 4mg/kg of sugammadex sodium 15 minutes after rocuronium administration
|Experimental: Sugammadex 8mg
Administer 8mg/kg of sugammadex 15 minutes after rocuronium administration
Drug: Sugammadex Injection 8mg/kg
Intravenous injection of 8mg/kg of sugammadex sodium 15 minutes after rocuronium administration
|Active Comparator: Conventional reversal
Administer conventional neuromuscular reversal agent (0.02mg/kg of atropine and 0.03mg/kg of neostigmine) 15 minutes after rocuronium administration
Drug: Neuromuscular reversal agent injection
Intravenous injection of 0.02mg/kg of atropine and 0.03mg/kg of neostigmine
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Inclusion Criteria: All of below
- Pediatric patients undergoing surgery under general anesthesia with requirement of
early reversal of neuromuscular blockade
- Aged between 2 and 17
- American Society of Anesthesiologists Physical Status Classification 1 and 2
Exclusion Criteria: Any of below
- One or more legal guardian declines to enroll in the study
- History of hypersensitivity to any anesthetic agents including rocuronium
- Presence of underlying cardiovascular or genitourinary disease
- Under usage of neuromuscular blocking agents before surgery
- Under usage of drugs influencing the effect of neuromuscular blocking agents
- History of malignant hyperthermia
- Anticipation of massive hemorrhage during surgery
Korea, Republic of, Jongro Gu
Seoul National University Hospital
Ministry of Food and Drug Safety, Korea
Principal Investigator: Hee-Soo Kim, M.D, Ph.D. Seoul National University Hospital
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.
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.
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.
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.