EUCTR2019-003033-42-ES进行中（未招募）1 期
The impact of deep versus standard muscle relaxation on intra-operative safety during laparoscopic surgery: a multicenter strategy study – EURO RELAX STUDY - EURO RELAX STUDY
INSTITUTO DE INVESTIGACIÓN SANITARIA LA FE0 个研究点目标入组 230 人开始时间: 2019年12月20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
- 230
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
- •In order to be eligible to participate in this study, a patient must meet all of the following criteria:
- •Patients scheduled for elective laparoscopic procedure with a complexity according to the BUPA classification for case complexity: ‘MAJOR’, ‘MAJOR PLUS’ or ‘COMPLEX MAJOR’
- •ASA class I-III
- •> 18 years of age
- •Ability to give oral and 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 230
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Low or intermediate complexity laparoscopic procedures (BUPA ‘SIMPLE’ or ‘INTER’)
- •Known or suspected neuromuscular disorders impairing neuromuscular function
- •Allergies to muscle relaxants, anesthetics or narcotics
- •A (family) history of malignant hyperthermia
- •Women who are or may be pregnant or are currently breast feeding
- •Chronic use of any type of opioid or psychotropic drug
- •Use of NSAID’s shorter than 5 days before surgery
- •Indication for rapid sequence induction
- •Contra-indication for sugammadex use (e.g. known sugammadex allergy or GFR<30 ml/min)
研究者
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