EUCTR2019-004581-18-DK进行中（未招募）1 期
Clinical effectiveness and safety of intraoperative methadone in patients undergoing cystectomy: a randomised, double-blind trial
one Nikolajsen0 个研究点目标入组 110 人开始时间: 2020年1月24日最近更新:
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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
- 110
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
- •All patients
- •= 18 years
- •Planned for bladder removal
- •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 55
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 55
排除标准
- •American Society of Anesthesiologists (ASA) physical status IV or V (21)
- •Prolonged QTc-interval assessed by electrocardiogram (> 440 milliseconds)
- •Existing treatment with a high risk of QTc-interval prolongation
- •Allergy to study drugs
- •Preoperative daily use of opioids
- •Inability to provide informed consent
- •Severe respiratory insufficiency (oxygen treatment at home)
- •Heart failure (ejection fraction < 30%)
- •Acute abdominal pain
- •Signs of severe liver dysfunction (cirrhosis, inflammation/hepatitis or liver malignancy)
- •Severe kidney insufficiency (estimated Glomerular Filtration Rate < 30 ml/min)
- •Treatment with rifampicin
- •Treatment with MAO-inhibitor during the last 14 days
- •Pregnancy
- •Nursing mothers
- •Phaeochromocytoma
- •Intraoperative conversion to open surgery (secondary inclusion criterion)
研究者
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