EUCTR2020-004826-47-DK进行中（未招募）1 期
Intraoperative methadone for postoperative pain management in spinal fusion surgery: a prospective, double-blind, randomised controlled trial - METASPINE
one Nikolajsen0 个研究点目标入组 150 人开始时间: 2020年10月22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
- 150
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) scheduled for elective spine surgery are screened for inclusion.
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Allergy to study drugs
- •American Society of Anaesthesiologists (ASA) physical status IV or V
- •Prolonged QTc-interval assessed by electrocardiogram (Male: >450 milliseconds, Female: >460 milliseconds)
- •Inability to provide informed consent
- •Severe respiratory insufficiency (Oxygen treatment at home)
- •Heart failure
- •Acute alcohol intoxication/delirium tremens
- •Increased intracranial pressure
- •Acute liver disease
- •Acute abdominal pain
- •Liver insufficiency
- •Kidney insufficiency (eGFR<30)
- •Pregnancy or breastfeeding
- •Existing treatment with medications prolonging the QT-interval (see appendix for details)
- •Existing treatment with opioids (at least the last 7 days) exceeding 60 mg morphine equivalents daily
- •Planned postoperative treatment with epidural analgesics and/or ketamine infusion
- •Treatment with rifampicin
- •Spinal surgery due to malignant disease
研究者
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