Measurement of Biomarkers of Neurodegeneration in Newborns After Exposure to Anesthetics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- S100β Umbilical
研究概览
简要总结
The purpose of the study is to quantify biomarkers of neural damage in neonates exposed to varying levels of volatile anesthetic in utero.
详细描述
This study will enroll 130 pregnant patients undergoing C-section or fetal surgery with EXIT (Ex Utero Intrapartum Treatment) procedures under epidural or general anesthesia with low (0.75 MAC) or high (2.5 MAC) concentrations of desflurane. Patients will be recruited from both the Hospital of the University of Pennsylvania (100 C Section) and Children's Hospital of Philadelphia (30 EXIT procedure).
The standard of care protocol for patients undergoing anesthesia for these cases will be followed throughout the surgery. These include monitoring and management of blood pressure, heart rate and rhythm, ventilation, oxygenation, temperature, and fluid status. Management of these parameters will be at the discretion of the clinical team. The choice of the anesthetic technique will also be at the discretion of the clinical team. Typical anesthetic management includes the following:
C-section under epidural anesthesia: induction and maintenance with 1.5% lidocaine, sodium bicarbonate and 1:200,000 epinephrine
C-section under general anesthesia: induction with propofol 2 mg/kg and succinylcholine 2 mg/kg intravenously; maintenance with desflurane 4.5-5%
EXIT procedure under general anesthesia: induction with propofol 2 mg/kg and succinylcholine 2 mg/kg intravenously; maintenance with desflurane 15-18%
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women delivering a child via cesarean section or EXIT procedure
- •Informed consent
排除标准
- •Known fetal neurologic defect
- •Known maternal neurologic abnormality
- •Sensitivity or allergy to medications used in the study
- •C-section under epidural anesthesia: induction and maintenance with 1.5% lidocaine, sodium bicarbonate and 1:200,000 epinephrine
- •C-section under general anesthesia: induction with propofol 2 mg/kg and succinylcholine 2 mg/kg intravenously; maintenance with desflurane 4.5-5%
- •EXIT procedure under general anesthesia: induction with propofol 2 mg/kg and succinylcholine 2 mg/kg intravenously; maintenance with desflurane 15-18%
结局指标
主要结局
S100β Umbilical
时间窗: 1 day
as measured by the concentration of biomarker in umbilical arterial and venous blood
次要结局
- Blood gas(1 day)
- S100β Blood(1 day)
- S100β Amniotic(1 day)