NCT00988520已完成3 期
Study of Efficacy, Pharmacokinetics and Safety of Continuous Intravenous Infusion of Org 9426 Following a Single Intubating Dose in Adult Patients Undergoing Operation Under Sevoflurane or Propofol Anesthesia.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 38
- 主要终点
- Infusion rate following intubation doses of 0.6 mg/kg or 0.9 mg/kg
研究概览
简要总结
The purpose of this study is to compare the infusion rate of Org 9426 following intubating dose of Org 9426 0.6 mg/kg or 0.9 mg/kg in adult surgical patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects at least 20 but under 65 years of age.
- •Subjects of asa class 1, 2 or 3 for general elective surgery.
- •Subjects who are not considered to be pregnant.
- •Subjects scheduled for elective surgery under sevoflurane or propofol anesthesia, with anticipated duration of surgery of 2-5 hours.
- •Subjects with normal laboratory values for serum electrolytes (Na+, K+, Cl-), BUN, creatinine, total bilirubin, ALP, ALAT and ASAT as judged by the investigator or the sub-investigator.
- •Subjects who received an explanation of the trial and agreed informed consent in writing to participate in the trial in advance.
排除标准
- •Subjects with renal dysfunction as a complication or in the history.
- •Subjects with serum creatinine level greater than 1.6 mg/dL.
- •Subjects with severe hepatic dysfunction as a complication or in the history.
- •Subjects with known significant metabolic or neuromuscular disorders.
- •Subjects with showing dyspnea, airway obstruction or bronchial asthma.
- •Subjects with a history of hypersensitivity to pancuronium bromide, vecuronium bromide or bromine.
- •Subjects with atopic diseases.
- •Subjects who have developed any systemic allergic symptoms related to drugs or general anesthesia.
- •Subjects receiving antihistamines and antiallergic agents for 1 month or more.
- •Subjects receiving any of the following drugs known to affect on the action of neuromuscular blocking agents on surgery day: calcium antagonists; anticonvulsants; aminoglycoside antibiotics; polypeptide antibiotics; or metronidazole.
- •Subjects under hypothermic anesthesia.
- •Subjects who participated as research subjects in another trial within the last 6 months or is now participating in other trials.
- •Other subjects judged to be ineligible as subjects in this trial by the discretion of the investigator or sub-investigator.
研究组 & 干预措施
0.6 mg/kg intubation dose under sevoflurane
Experimental
干预措施: Rocuronium bromide (Drug)
0.6 mg/kg intubation dose under sevoflurane
Experimental
干预措施: Sevoflurane (Drug)
0.9 mg/kg intubation dose under sevoflurane
Experimental
干预措施: Rocuronium bromide (Drug)
0.9 mg/kg intubation dose under sevoflurane
Experimental
干预措施: Sevoflurane (Drug)
continuous dose following 0.6 mg/kg intubation dose + propofol
Experimental
干预措施: Rocuronium bromide (Drug)
continuous dose following 0.6 mg/kg intubation dose + propofol
Experimental
干预措施: Propofol (Drug)
continuous dose following 0.9 mg/kg intubation dose + propofol
Experimental
干预措施: Rocuronium bromide (Drug)
continuous dose following 0.9 mg/kg intubation dose + propofol
Experimental
干预措施: Propofol (Drug)
结局指标
主要结局
Infusion rate following intubation doses of 0.6 mg/kg or 0.9 mg/kg
时间窗: 90 minutes after start of continuous infusion
次要结局
未报告次要终点
研究者
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