EUCTR2021-001503-33-FR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
CHRU de Nancy0 个研究点目标入组 184 人开始时间: 2021年5月6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
- 184
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
- 性别
- All
入选标准
- •1/ Patients scheduled for elective laparoscopic procedure with a complexity according to the BUPA classification for case complexity: ‘MAJOR’, ‘MAJOR PLUS’ or ‘COMPLEX MAJOR’
- •2/ ASA class I-III
- •3/ > 18 years of age
- •4/ 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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •1/ Low or intermediate complexity laparoscopic procedures (BUPA ‘SIMPLE’ or ‘INTER’)
- •2/ Known or suspected neuromuscular disorders impairing neuromuscular function
- •3/ Allergies to muscle relaxants, anesthetics or narcotics mentioned in paragraph 7
- •4/ A (family) history of malignant hyperthermia
- •5/ Women who are or may be pregnant or are currently breast feeding
- •6/ Chronic use of any type of opioid or psychotropic drug
- •7/ Use of NSAID’s shorter than 5 days before surgery
- •8/ Indication for rapid sequence induction
- •9/ Contra-indication for sugammadex use (e.g. known sugammadex allergy or GFR<30 ml/min)
- •10/ Persons deprived of liberty for judicial or administrative decision
- •11/ Persons in health or social institutions for another reason than research
- •12/ Minors (non emancipated)
- •13/ Adult persons under legal protection (any form of public guardianship)
- •14/ Persons incapable of giving consent and not under legal protection
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