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临床试验/NCT07571811
NCT07571811尚未招募不适用

Pharmacokinetic and Pharmacodynamic Investigations of Fetal Anesthesia During Maternal Fetal Surgery

Boston Children's Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2026年5月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gwen Owens

Instructor of Anesthesia, Harvard Medical School

Boston Children's Hospital

研究点 (1)

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