Pharmacokinetic-pharmacodynamic Analysis of Sugammadex for Conventional Reversal in Children
- Conditions
- Anesthesia, GeneralNeuromuscular Blockade
- Interventions
- Drug: Neuromuscular reversal agent injection
- Registration Number
- NCT04347486
- Lead Sponsor
- Seoul National University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sugammadex 8mg Sugammadex Injection 8mg/kg Administer 8mg/kg of sugammadex on reappearance of T2 by Train-of-Four stimulation Sugammadex 2mg Sugammadex Injection 2mg/kg Administer 2mg/kg of sugammadex on reappearance of T2 by Train-of-Four stimulation Conventional reversal Neuromuscular reversal agent injection Administer conventional neuromuscular reversal agent (0.02mg/kg of atropine and 0.03mg/kg of neostigmine) on reappearance of T2 by Train-of-Four stimulation Sugammadex 4mg Sugammadex Injection 4mg/kg Administer 4mg/kg of sugammadex on reappearance of T2 by Train-of-Four stimulation
- Primary Outcome Measures
Name Time Method 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
Name Time Method Plasma concentrations From anesthetic induction to 480 minutes after sugammadex administration Plasma concentrations of rocuronium and sugammadex sodium
Trial Locations
- Locations (1)
SNUH
🇰🇷Seoul, Jongro Gu, Korea, Republic of