NCT00420680已完成3 期
A Multi -Center, Randomized, Parallel-Group, Placebo-Controlled, Safety Assessor-Blinded Trial, Evaluating the Safety and Efficacy of Sugammadex in Cardiac Patients
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
- 120
- 主要终点
- to evaluate the safety of 2.0 and 4.0 mg/kg sugammadex in cardiac patients compared to placebo
研究概览
简要总结
The purpose of this study is to evaluate the safety of 2.0 mg/kg and 4.0 mg/kg sugammadex given as a reversal agent at reappearance of T2 after 0.6 mg/kg rocuronium in cardiac 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cardiac patients of NYHA Class II to III
- •ASA class maximally 4
- •Age at least 18
- •Scheduled for elective, non-cardiac surgery under general anesthesia with propofol in the supine position, with planned muscle relaxation using rocuronium and allowing for 12-lead ECG assessment during surgery;
- •Given written informed consent.
排除标准
- •Disorders interfering with the reliability of the assessments (e.g. ECG measurements), such as paroxysmal atrial fibrillation or the presence of a pacemaker
- •Known or suspected neuromuscular disorders impairing NMB
- •Known or suspected significant renal dysfunction
- •Known or suspected (family) history of malignant hyperthermia
- •Known or suspected allergy to narcotics, muscle relaxants or other medication used during general anesthesia
- •Intended) use of medication expected to interfere with the effect of rocuronium as given in this trial, based on the dose and/or the time of administration (such as antibiotics, anticonvulsants and Mg2+ )
- •Pregnancy (pregnancy to be excluded for women both from medical history and by an hCG test within 24 h before surgery, except for women who were not of childbearing potential, i.e. at least 2 years menopausal or have undergone tubal ligation or a hysterectomy)
- •Childbearing potential without using any method of birth control or using only hormonal contraception as birth control (subjects were allowed to participate if they were willing to use a condom, or a diaphragm with spermicide, or IUD, or have a vasectomized partner (>6 months) or abstinence, for one month after participation in the trial)
- •Breast -feeding
- •Prior participation in any trial with Org 25969
- •Participation in another clinical trial not pre -approved by Organon, within 30 days of entering into trial 19.4.309
研究组 & 干预措施
Arm 1
Experimental
Sugammadex 2.0 mg/kg
干预措施: Sugammadex (Drug)
Arm 2
Experimental
Sugammadex 4.0 mg/kg
干预措施: Sugammadex (Drug)
Arm 3
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
to evaluate the safety of 2.0 and 4.0 mg/kg sugammadex in cardiac patients compared to placebo
时间窗: after surgery
次要结局
- to evaluate the time to recovery from a neuromuscular block induced by rocuronium after reversal at reappearance of T2 by 2.0 and 4.0 mg/kg sugammadex in cardiac patients(after surgery)
研究者
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