Pharmacokinetics of Sedatives and Analgesics During Extracorporeal Membrane Oxygenation (ECMO) Support
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- change in plasma concentrations of morphine
研究概览
简要总结
This study will measure plasma concentrations of dexmedetomidine, fentanyl, morphine and midazolam in pediatric patients supported with extracorporeal membrane oxygenation (ECMO) aiming to understand the pharmacokinetics of these drugs in this setting.
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
- 0 Days 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •supported on ECMO
- •receiving one or a combination of the following drugs dexmedetomidine, fentanyl, midazolam or morphine as part of sedation management
排除标准
- 未提供
研究组 & 干预措施
Pediatric Patients on ECMO Support
干预措施: Dexmedetomidine (Drug)
Pediatric Patients on ECMO Support
干预措施: Fentanyl (Drug)
Pediatric Patients on ECMO Support
干预措施: Midazolam (Drug)
Pediatric Patients on ECMO Support
干预措施: Morphine (Drug)
结局指标
主要结局
change in plasma concentrations of morphine
时间窗: Throughout the duration of sedation management with morphine at baseline, 30, 60, 120 minutes and then at 4, 6, 12 hours after each bolus or change in infusion and then at 30,60, 90, 120, 240minutes and 4 hours after the drug is stopped
Change in plasma concentrations of dexmedetomidine
时间窗: Throughout the duration of sedation management with dexmedetomidine at baseline, 30, 60, 120 minutes and then at 4, 6, 12 hours after each bolus or change in infusion and then at 30,60, 90, 120, 240minutes and 4 hours after the drug is stopped
change in plasma concentrations of fentanyl
时间窗: Throughout the duration of sedation management with fentanyl at baseline, 30, 60, 120 minutes and then at 4, 6, 12 hours after each bolus or change in infusion and then at 30,60, 90, 120, 240minutes and 4 hours after the drug is stopped
change in plasma concentrations of midazolam
时间窗: Throughout the duration of sedation management with midazolam at baseline, 30, 60, 120 minutes and then at 4, 6, 12 hours after each bolus or change in infusion and then at 30,60, 90, 120, 240minutes and 4 hours after the drug is stopped
次要结局
未报告次要终点
研究者
Viviane Nasr
Cardiac Anesthesiologist
Boston Children's Hospital
