2024-519224-24-00招募中4 期
Methadone versus fentanil and oxycodone for post-operative pain reduction in patients undergoing coronary artery bypass grafting and/or valve surgery – a placebo-controlled, double-blind, randomized clinical trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- The primary endpoint will be cumulated intravenous morphineequivalent consumption within 48 hours from surgery
研究概览
简要总结
The primary objective of this trial is to investigate the efficacy of a single‐dose of Intraoperative methadone, administered after induction of anesthesia, compared to administration of fentanil and oxycodone per-operatively (usual care), on the endpoint postoperative opioid consumption in adult subjects undergoing elective or subacute CABG and/or valve surgery.
研究设计
- 分配方式
- Randomized
- 主要目的
- Methadone versus fentanil and oxycodone for post-operative pain reduction
- 盲法
- Double (Analyst, Carer, Investigator, Monitor, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years 2) Scheduled for CABG and/or valve surgery.
排除标准
- •Acute surgery 2) Pregnancy or currently breastfeeding 3) Know elongated Qt syndrome 4) Prolonged QT‐interval assessed by electrocardiogram > 500ms 5) Existing treatment with methadone 6) Preadmission treatment with opioids 7) Allergy to methadone 8) Inability to provide informed consent 9) Dialysis There will be no general restrictions on inclusion into other
结局指标
主要结局
The primary endpoint will be cumulated intravenous morphineequivalent consumption within 48 hours from surgery
The primary endpoint will be cumulated intravenous morphineequivalent consumption within 48 hours from surgery
次要结局
- Intraoperative need for inotropes and vasopressors
- Pain intensity assessed by the Numeric Rating Scale (NRS) at rest and at cough.
- Pain intensity assessed by the Numeric Rating Scale (NRS) during physiotherapeutic testing
- Time from arrival in CICU until patient extubating and mobilization.
- CICU Length of stay (time from arrival at CICU until booking of transfer to the ward)
- Days until bowel function (movement, Flatus, stool)
- Quality of Recovery 1516 at postoperative day 0, 1, 2, 3, 30 and 90.
- Quality of life assessed by the SF-3617 after 90 days.
- Chronic pain assessment at 30 and 90 days after surgery.
- Time to hospital discharge.
- 3 months mortality
- Reported occurrence of postoperative arrythmias
研究者
Mark Soegaard Niegsch
Scientific
Rigshospitalet
研究点 (1)
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