EUCTR2007-007951-14-GB进行中（未招募）1 期
A multi-center, randomized, parallel-group, comparative, active-controlled, safety-assessor blinded trial in adult subjects comparing the efficacy and safety of sugammadex administered at 1-2 PTC with neostigmine administered at reappearance of T2 in subjects undergoing laparoscopic cholecystectomy or appendectomy under propofol anesthesia - Moonlight
V Organon0 个研究点目标入组 140 人开始时间: 2008年4月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Male or female subjects:
- •Subjects of ASA class 1-3
- •Subjects of age above or equal to the age of 18 years
- •Subjects who are scheduled to undergo a laparoscopic cholecystectomy or appendectomy under general anesthesia requiring neuromuscular relaxation with rocuronium, and if applicable, maintenance of neuromuscular blockade
- •Subjects who have given written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects in whom a difficult intubation because of anatomical malformations is expected
- •Subjects known or suspected to have neuromuscular disorders affecting NMB
- •Subjects known or suspected to have a significant renal dysfunction
- •Subjects known or suspected to have a severe hepatic dysfunction
- •Subjects known or suspected to have (family) history of malignant hyperthermia
- •Subjects known or suspected to have an allergy to opioids, muscle relaxants or other medication used during general anesthesia
- •Subjects in whom the use of neostigmine and/or atropine is contraindicated
- •Female subjects who are pregnant (pregnancy will be excluded for women both from medical history and by an hCG test within 24h before surgery, except for women who are not of childbearing potential, i.e. at least 2 years menopausal or have undergone tubal ligation or an hysterectomy)
- •Female subjects who are breast-feeding
- •Subjects who participated in another clinical trial not pre-approved by the sponsor, within 30 days of entering into trial 19.4.318
- •Subjects who have already participated in a sugammadex trial
研究者
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