Pharmacokinetic-pharmacodynamic Analysis of Reversal of Rocuronium-induced Neuromuscular Blockade by Sugammadex in Children
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Neuromuscular Recovery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Sugammadex 2mg
Administer 2mg/kg of sugammadex 15 minutes after rocuronium administration
干预措施: Sugammadex Injection 2mg/kg (Drug)
Sugammadex 4mg
Administer 4mg/kg of sugammadex 15 minutes after rocuronium administration
干预措施: Sugammadex Injection 4mg/kg (Drug)
Sugammadex 8mg
Administer 8mg/kg of sugammadex 15 minutes after rocuronium administration
干预措施: Sugammadex Injection 8mg/kg (Drug)
Conventional reversal
Administer conventional neuromuscular reversal agent (0.02mg/kg of atropine and 0.03mg/kg of neostigmine) 15 minutes after rocuronium administration
干预措施: Neuromuscular reversal agent injection (Drug)
结局指标
主要结局
Neuromuscular Recovery
时间窗: 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.
次要结局
- Plasma Concentrations(From anesthetic induction to 480 minutes after sugammadex administration)
研究者
Hee-Soo Kim
MD, PhD, Professor
Seoul National University Hospital