NCT06720415已完成4 期
Comparison of Oral and Intravenous Methadone for Analgesia in Cardiac Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Opioid Use in Morphine Milligram Equivalents 24 Hours After Extubation
研究概览
简要总结
The purpose of this study is to compare the effects of administration of oral methadone preoperatively and intravenous methadone upon induction of general anesthesia on postoperative pain for patients undergoing elective cardiac surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing elective cardiac surgery as the first case of the day in an operating room
排除标准
- •Chronic pain requiring opioid medications as an outpatient
- •Opioid use disorder on medication assistance treatment
- •Prolonged QTc > 500ms
- •Chronic kidney disease with eGFR < 30mL/min
- •Documented cirrhosis
- •Intolerance to methadone
- •Subsequent surgeries after index surgery
研究组 & 干预措施
Oral methadone, immediately prior to transport
Experimental
干预措施: Oral methadone, immediately prior to transport (Drug)
Intravenous methadone
Active Comparator
干预措施: Intravenous methadone (Drug)
结局指标
主要结局
Opioid Use in Morphine Milligram Equivalents 24 Hours After Extubation
时间窗: From hospital admission for surgery to 24 hours after the patient is extubated postoperatively
Oral morphine milligram equivalents
次要结局
- Opioid Use in Morphine Milligram Equivalents 48 Hours After Extubation(From hospital admission for surgery to 48 hours after the patient is extubated postoperatively)
- Opioid Use in Morphine Milligram Equivalents 72 Hours After Extubation(From hospital admission for surgery to 72 hours after the patient is extubated postoperatively)
- Pain Score 6 Hours After Extubation(From hospital admission for surgery to 6 hours after extubation postoperatively)
- Pain Score 12 Hours After Extubation(From hospital admission for surgery to 12 hours after extubation postoperatively)
- Pain Score 24 Hours After Extubation(From hospital admission for surgery to 24 hours after extubation postoperatively)
- Pain Score 48 Hours After Extubation(From hospital admission for surgery to 48 hours after extubation postoperatively)
- Pain Score 72 Hours After Extubation(From hospital admission for surgery to 72 hours after extubation postoperatively)
- Time to Extubation(From the time the patient arrives in the ICU intubated until the time the patient is successfully extubated.)
- Opioid Use in MMEs Prior to Extubation(From the time the patient arrives in the ICU intubated until the time the patient is successfully extubated.)
研究者
Krishnan Ramanujan
Principal Investigator
Mayo Clinic
研究点 (2)
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