Pharmacokinetic-pharmacodynamic Analysis of Sugammadex in Children
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
Other Names:
|
| 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
Other Names:
|
| 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
Other Names:
|
| 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
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Neuromuscular recovery [up to 30 minutes to 1 hour]
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.
Secondary Outcome Measures
- Plasma concentrations [From anesthetic induction to 480 minutes after sugammadex administration]
Plasma concentrations of rocuronium and sugammadex sodium
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | SNUH | Seoul | Jongro Gu | Korea, Republic of | 15710 |
Sponsors and Collaborators
- Seoul National University Hospital
- Ministry of Food and Drug Safety, Korea
Investigators
- Principal Investigator: Hee-Soo Kim, M.D, Ph.D., Seoul National University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 1904-149-1029