NCT07221617招募中4 期
Oral Methadone In Cardiac Surgery
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Amount of opioid medication used 72 hours post-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
- Triple (Participant, Investigator, Outcomes Assessor)
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
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
- •Admitted inpatient in an intensive care unit (ICU) immediately prior to surgery
- •Pregnancy at the time of surgery
- •Subsequent surgeries after index surgery
研究组 & 干预措施
Intravenous methadone intraoperatively
Active Comparator
Subjects in the IV methadone arm will receive methadone intravenously during cardiac surgery
干预措施: Methadone, intravenously (Drug)
Oral methadone, immediately prior to transport
Experimental
Subjects in the oral methadone arm will receive methadone orally prior to cardiac surgery
干预措施: Methadone, oral (Drug)
结局指标
主要结局
Amount of opioid medication used 72 hours post-extubation
时间窗: From hospital admission for surgery to 72 hours after the patient is extubated postoperatively
Opioid medication used at 72 hours post-extubation will be reported in morphine milligram equivalents
次要结局
- Amount of opioid medication used 24 hours post-extubation(From hospital admission for surgery to 24 hours after the patient is extubated postoperatively)
- Amount of opioid medication used 48 hours post-extubation(From hospital admission for surgery to 48 hours after the patient is extubated postoperatively)
- Pain scores after extubation(6 hours, 12 hours, 24 hours, 48 hours, and 72 hours after extubation)
- Amount of opioid medication used 24 hours post-extubation(From hospital admission for surgery to 24 hours after the patient is extubated postoperatively)
- Amount of opioid medication used 48 hours post-extubation(From hospital admission for surgery to 48 hours after the patient is extubated postoperatively)
- Amount of opioid medication required throughout hospitalization(From the time the patient is extubated until the time the patient leaves the hospital, approximately 10 days. Safety to leave the hospital is determined by the cardiac surgery team and can be several days after surgery or longer.)
- Amount of opioid medication required prior to extubation(From arrival in the ICU until extubation, approximately 6 hours. Safety of extubation is determined by the intensive care unit team and usually occurs within several hours of ICU arrival, although this can be variable.)
- Pain scores after extubation(6 hours, 12 hours, 24 hours, 48 hours, and 72 hours after extubation)
- Time to extubation(From the time the patient arrives in the ICU intubated until the time they are successfully extubated, approximately 12 hours. Safety of extubation is determined by the ICU team and usually occurs within several hours, although this can be variable.)
研究者
Krishnan Ramanujan
Principal Investigator
Mayo Clinic
研究点 (1)
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