Pharmacokinetics of Morphine and Oxycodone in Frail Elderly Undergoing Cardiac Surgery - AGE AWARE II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Oxymorphone concentration in blood over time
研究概览
简要总结
- Single centre observational cohort study.
- 20 older patients undergoing cardiac surgery who receive standard of care pain treatment.
- Postoperative ICU: blood sampling to determine morphine and metabolite (M3G, M6G, noroxycodone and oxymorphone) pharmacokinetics
- After ICU discharge on general ward: blood sampling to determine morphine, oxycodone and metabolite (M3G, M6G, noroxycodone and oxymorphone) pharmacokinetics
- During study monitoring of pain scores, total opioid consumption, side effects (e.g. nausea, vomiting, pruritus), sedation and delirium scores.
详细描述
Postoperative pain after cardiac surgery in elderly patients is common and leads to postoperative complications. Opioids play an important role in treatment of postoperative pain after cardiac surgery. In frail elderly after cardiac surgery however dosing schemes for opioids are still unknown, potentially leading to inadequate treatment of pain and/or safety issues.
- Single center observational cohort study
- The study population includes frail patients ≥70 years undergoing elective cardiac surgery.
- Primary endpoints of this study is the concentration of morphine, oxycodone and metabolites in blood over time on behalf of pharmacokinetic modelling.
- Secondary endpoints of this study are the pharmacodynamic parameters of morphine, oxycodone and metabolites (M3G, M6G, noroxycodone and oxymorphone) in blood in frail patients; such as pain scores, postoperative opioid consumption, vital signs, side effects of opioids and the influence of covariates such as frailty, serum creatinine, Glomerular Filtration Rate (GFR) on the pharmacokinetics and pharmacodynamics of morphine and oxycodone.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥70 years undergoing elective cardiac surgery.
排除标准
- •Patients undergoing transcatheter aortic valve replacement or mitral valve repair
- •Contra-indication for morphine and/or oxycodone
结局指标
主要结局
Oxymorphone concentration in blood over time
时间窗: Until three consecutive days after ICU discharge
Analysis of serum concentrations of Oxymorphone, metabolite of oxycodone, for pharmacokinetic modelling
M3G concentration in blood over time
时间窗: Until three consecutive days after ICU discharge
Analysis of serum concentrations of M3G, metabolite of morphine, for pharmacokinetic modelling
M6G concentration in blood over time
时间窗: Until three consecutive days after ICU discharge
Analysis of serum concentrations of M6G, metabolite of morphine, for pharmacokinetic modelling
Noroxycodone concentration in blood over time
时间窗: Until three consecutive days after ICU discharge
Analysis of serum concentrations of Noroxycodone, metabolite of oxycodone, for pharmacokinetic modelling
次要结局
- Numeric Rating Scale (NRS; 0-10, 0 = none, 10 = severe)(Until three consecutive days after ICU discharge)
- Side effects of opioids(Until three consecutive days after ICU discharge)
- Vital sign observation: bloodpressure (in mmHg) by nurse(Until three consecutive days after ICU discharge)
- Postoperative opioid consumption(Until three consecutive days after ICU discharge)
- Vital sign observation: heartrate (in beats/minute) by nurse(Until three consecutive days after ICU discharge)
- Vital sign observation: saturation (in %) by nurse(Until three consecutive days after ICU discharge)
研究者
dr. P. Noordzij
Principal Investigator
St. Antonius Hospital