Pharmacokinetics of Dexmedetomidine in Children During Cardiopulmonary Bypass (CPB)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Plasma pharmacokinetics (clearance, volume of distribution, area under the curve, oxygenator extraction efficiency) of dexmedetomidine in children supported with cardiopulmonary bypass
研究概览
简要总结
Dexmedetomidine is increasingly used for sedation in children placed on cardiopulmonary bypass for heart surgery. It is also often used after surgery and may be particularly helpful for children with heart disease. In order for this medication to be helpful and to minimize risks associated with taking the medication, it is important to provide correct dosing for this medication. Based on evidence from studies of other medications used during heart surgery, it is likely that dosing of dexmedetomidine while on cardiopulmonary bypass is different from dosing in other settings. The purpose of this study is to evaluate how the heart-lung bypass machine affects dexmedetomidine levels in the body.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •< 2 years of age
- •Sufficient venous access to permit administration of study medication.
- •Supported with cardiopulmonary bypass (CPB)
- •Receiving dexmedetomidine per standard of care.
- •Availability and willingness of the parent/legal guardian to provide written informed consent.
排除标准
- •<38 weeks post menstrual age
- •Any concomitant condition, which in the opinion of the investigator would preclude a subject's participation in the study.
- •Previous participation in this study
- •CPB circuit primed with clear fluid
结局指标
主要结局
Plasma pharmacokinetics (clearance, volume of distribution, area under the curve, oxygenator extraction efficiency) of dexmedetomidine in children supported with cardiopulmonary bypass
时间窗: Data will be collected at the following approximate time points: 0h, 0.5h, 0.75h, and 2h after infusion initiation; 0.25h, 0.75h, and 2h after bypass initiation; 0.5h prior to bypass termination, 0.25h, 1h, 3h, 7h, and 10h after bypass termination
The plasma pharmacokinetics of dexmedetomidine will include * Clearance (CL) * Volume of distribution (V) * Area under the curve (AUC) * Oxygenator extraction efficiency
次要结局
- COMFORT behavioral score as a measure of dexmedetomidine pharmacodynamics(assessed at time 0, upon presentation to the intensive care unit after surgery, and 12-24 hours from study drug initiation.)
- Accessory sedative and analgesic use as a measure of dexmedetomidine pharmacodynamics(up to 48 hours after study drug initiation)