NCT00379613已完成2 期
A Multi-Center Randomized Safety Assessor-Blinded Placebo-Controlled Parallel and Dose Escalating Dose-Finding Trial in Subjects of ASA 1 - 2 to Assess the Safety, Efficacy and PK of Sugammadex Administered at 5 Min. After Administration of 1.2 mg/kg Esmeron
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 主要终点
- Time from start administration of sugammadex to recovery T4/T1 ratio to 0.9.
研究概览
简要总结
The purpose of this study is to determine the optimal dose of sugammadex when this compound is administered during deep neuromuscular block. Sugammadex is administered shortly (5 minutes) after administration of a high dose (1.2 mg/kg) of the neuromuscular blocking agent rocuronium . Under these circumstance the neuromuscular block is deep. The safety and pharmacokinetics of sugammadex are also studied.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA 1 - 2 between the ages of 18 and 64, inclusive
- •Scheduled for surgical procedures with an anticipated duration of anesthesia of at least 90 minutes, without further need for muscle relaxation other than for intubation
- •Scheduled for surgery 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 known to interfere with neuromuscular blocking agents such as anticonvulsants and Mg2+
- •Subjects who had already participated in CT 19.4.205
- •Subjects who had participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into CT 19.4.205
- •Female subjects who are pregnant: in females pregnancy was to be excluded both from medical history and by an hCG test within 24 hours before surgery except in females who were not of childbearing potential i.e. at least 2 years postmenopausal or underwent tubal ligation or an hysterectomy
- •Females of childbearing potential not using an acceptable method of birth control: condom or diaphragm with spermicide, vasectomized partner (>6 months), IUD, abstinence
- •Subjects giving breast-feeding
研究组 & 干预措施
1
Placebo Comparator
rocuronium + 16.0 mg/kg Org 25969
干预措施: Placebo (Drug)
2
Experimental
rocuronium + 2.0 mg/kg Org 25969
干预措施: sugammadex (Drug)
3
Experimental
rocuronium + 4.0 mg/kg Org 25969
干预措施: sugammadex (Drug)
4
Experimental
rocuronium + 8.0 mg/kg Org 25969
干预措施: sugammadex (Drug)
5
Experimental
rocuronium + 12.0 mg/kg Org 25969
干预措施: sugammadex (Drug)
结局指标
主要结局
Time from start administration of sugammadex to recovery T4/T1 ratio to 0.9.
时间窗: After administration of rocuronium
次要结局
- Time from start administration of sugammadex to recovery T4/T1 ratio to 0.7; Time from start administration of sugammadex to recovery T4/T1 ratio to 0.8.(After administration of rocuronium)
研究者
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