NCT00984633已完成3 期
Study of Efficacy, Pharmacokinetics, and Safety of Bolus Maintenance Doses of Org 9426 Following a Single Intubating Dose in Adult Subjects 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
- 40
- 主要终点
- Clinical duration of 2 doses of Org 9426 in maintenance of muscle relaxation
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, pharmacokinetics, and safety of Org 9426 in maintenance of muscle relaxation in adult subjects undergoing general elective surgery.
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 about 1.5-3 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.
- •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 the sub-investigator.
研究组 & 干预措施
0.6 mg/kg intubation dose + sevoflurane
Experimental
干预措施: Rocuronium bromide (Org 9426) (Drug)
0.6 mg/kg intubation dose + sevoflurane
Experimental
干预措施: Sevoflurane (Drug)
0.9 mg/kg intubation dose + sevoflurane
Experimental
干预措施: Rocuronium bromide (Org 9426) (Drug)
0.9 mg/kg intubation dose + sevoflurane
Experimental
干预措施: Sevoflurane (Drug)
0.6 mg/kg intubation dose + propofol
Experimental
干预措施: Rocuronium bromide (Org 9426) (Drug)
0.6 mg/kg intubation dose + propofol
Experimental
干预措施: Propofol (Drug)
0.9 mg/kg intubation dose + propofol
Experimental
干预措施: Rocuronium bromide (Org 9426) (Drug)
0.9 mg/kg intubation dose + propofol
Experimental
干预措施: Propofol (Drug)
结局指标
主要结局
Clinical duration of 2 doses of Org 9426 in maintenance of muscle relaxation
时间窗: Time from intubating dose to bolus maintenance dose
次要结局
未报告次要终点
研究者
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