Anesthesia, General, Neuromuscular Blockade
Conditions
Keywords
Sugammadex, Pharmacokinetics, Pharmacodynamics, Pediatric anesthesia
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.
Detailed description
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.
Interventions
Intravenous injection of 2mg/kg of sugammadex sodium on reappearance of T2
Intravenous injection of 4mg/kg of sugammadex sodium on reappearance of T2
Intravenous injection of 8mg/kg of sugammadex sodium on reappearance of T2
Intravenous injection of 0.02mg/kg of atropine and 0.03mg/kg of neostigmine
Sponsors
Ministry of Food and Drug Safety, Korea
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentrations | From anesthetic induction to 480 minutes after sugammadex administration | Plasma concentrations of rocuronium and sugammadex sodium |
Countries
South Korea
Outcome results
None listed