Pharmacokinetic and Pharmacodynamic Investigations of Fetal Anesthesia During Maternal Fetal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration (Cmax) of fetal anesthesia
研究概览
简要总结
This study examines how three medications commonly used during fetal surgery, fentanyl, rocuronium, and atropine, behave in the fetus. The primary goal is to understand their pharmacokinetics (how the drugs are absorbed, distributed, and cleared), pharmacodynamics (how they affect fetal physiology), and how they transfer between mother and fetus through the placenta. The secondary goal is to measure drug levels in discarded fetal blood samples collected during clinically indicated procedures and relate those levels to fetal heart rate, heart rate variability, movement, gestational age, and fetal size. An optional maternal blood draw component will allow comparison of maternal and fetal drug concentrations to better understand placental transfer. The study does not change clinical care or require extra fetal procedures, and findings may help create safer, evidence-based fetal anesthesia dosing strategies tailored to gestational age.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 13 Years 至 —(Child, Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant and undergoing maternal-fetal surgery requiring clinically indicated fetal anesthesia and planned fetal blood sampling as part of usual fetal care
- •Fetus is with or without congenital heart disease
排除标准
- •Patient or fetus have any known liver or kidney disease
- •Patient or fetus has any known allergy to fentanyl, rocuronium, or atropine
- •Patient has taken inhibitors, inducers or substrates of CYP3A4 other than midazolam (including erythromycin, ranitidine, verapamil, antihistamines, and dextromethorphan) within 24 hours of surgery.
研究组 & 干预措施
Pregnant women undergoing maternal-fetal surgery
Pregnant women undergoing maternal-fetal surgery requiring fetal anesthesia. This study is purely observational.
结局指标
主要结局
Maximum plasma concentration (Cmax) of fetal anesthesia
时间窗: 2 years
Characterize the plasma concentrations / pharmacokinetics profile, specifically the peak plasma concentration (Cmax) of commonly used fetal anesthetics, investigate the pharmacodynamic effects of anesthetics on fetus, assess the maternal-fetal transfer of anesthetics during surgery, and identify potential variations during different stages of fetal development.
Area under the plasma concentration versus time curve (AUC) of fetal anesthesia
时间窗: 2 years
Characterize the plasma concentrations / pharmacokinetics profile, specifically the area under the plasma concentration versus time curve (AUC) of commonly used fetal anesthetics, investigate the pharmacodynamic effects of anesthetics on fetus, assess the maternal-fetal transfer of anesthetics during surgery, and identify potential variations during different stages of fetal development.
次要结局
- Maternal blood concentration of fetal anesthesia(2 years)
- Fetal blood concentration of maternal anesthesia(2 years)
研究者
Gwen Owens
Instructor of Anesthesia, Harvard Medical School
Boston Children's Hospital
