NCT00451100已完成3 期
Comparison of Rocuronium and Org25969 With Cisatracurium and Neostigmine When Neuromuscular Block is Reversed at Reappearance of T2
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
- 84
- 主要终点
- Time from start administration of Org 25969/neostigmine to recovery T4/T1 ratio to 0.9
研究概览
简要总结
The purpose of this study was to demonstrate in adult patients a faster recovery from a neuromuscular block with 2.0 mg/kg Org 25969 (sugammadex) after rocuronium as compared to 50 ug/kg neostigmine after cisatracurium when administered at reappearance of T2
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of ASA 1 - 4;
- •Subjects above or equal to the age of 18;
- •Scheduled for surgical procedures with a general anesthesia requiring neuromuscular relaxation with the use of rocuronium or cisatracurium;
- •Scheduled for surgical procedures in supine position;
- •Given written informed consent.
排除标准
- •Subjects in whom a difficult intubation because of anatomical malformations was expected;
- •Subjects known or suspected to have neuromuscular disorders impairing neuromuscular block (NMB) and/or significant renal dysfunction;
- •Subjects known or suspected to have a (family) history of malignant hyperthermia;
- •Subjects known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
- •Subjects receiving medication in a dose and/or at a time point known to interfere with neuromuscular blocking agents such as antibiotics, anticonvulsants and Mg2+;
- •Subjects in whom the use of neostigmine and/or glycopyrrolate may be contraindicated;
- •Subjects who had already participated in an Org25969 trial;
- •Subjects who had participated in another clinical trial (not pre-approved by NV Organon) within 30 days of entering into CT 19.4.
- •Female subjects who are pregnant:
- •Female subjects of childbearing potential not using any method of birth control: condom or using only hormonal contraception as birth control;
- •Female subjects who were breast -feeding.
研究组 & 干预措施
Sugammadex
Experimental
2.0 mg/kg Org 25969 (sugammadex)
干预措施: Sugammadex (Drug)
Neostigmine
Active Comparator
50 ug/kg neostigmine
干预措施: neostigmine (Drug)
结局指标
主要结局
Time from start administration of Org 25969/neostigmine to recovery T4/T1 ratio to 0.9
时间窗: After surgery
次要结局
- Time from start administration of Org 25969/neostigmine to recovery T4/T1 ratio to 0.7 and 0.8(After surgery)
- Assessment of clinical signs of recovery (level of consciousness, 5 sec head lift, and general muscle weakness)(after surgery)
研究者
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