Neurodegeneration in Newborns After Anesthetics
Measurement of Biomarkers of Neurodegeneration in Newborns After Exposure to Anesthetics
研究概览
详细说明
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%
- After the baby is delivered, and the umbilicus is cut, two ml of blood will be taken from the umbilical vein and artery on the placenta side. A portion of the blood will be used for the blood gas and the remainder will be used for the S100B study assay.
- 5 ml of blood will be taken from the mother via the existing intravenous catheter.
- 5 ml of amniotic fluid will be obtained at hysterotomy and will be used for the S100B study assay.
All subjects will receive standard of care post operative clinical care and monitoring.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- University of Pennsylvania
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Women delivering a child via cesarean section or EXIT procedure
- Informed consent
Exclusion Criteria:
- 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%
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
---|---|
pregnant women
Women undergoing c-section or EXIT procedure
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Fluids tested for biomarker S100beta
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
S100β Umbilical
大体时间:1 day
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as measured by the concentration of biomarker in umbilical arterial and venous blood
|
1 day
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
S100β Amniotic
大体时间:1 day
|
as measured by the concentration of biomarker in maternal amniotic fluid
|
1 day
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S100β Blood
大体时间:1 day
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as measured by the concentration of biomarker in maternal blood
|
1 day
|
Blood gas
大体时间:1 day
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as measured by the results of umbilical arterial and venous blood
|
1 day
|
合作者和调查者
调查人员
- 首席研究员:Huafeng Wei, MD、University of Pennsylvania
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Fluid collection的临床试验
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University of California, San FranciscoNational Heart, Lung, and Blood Institute (NHLBI); National Institute of Nursing Research (NINR)完全的
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Cliniques universitaires Saint-Luc- Université...Université de Liège招聘中
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Fondazione IRCCS Ca' Granda, Ospedale Maggiore...Opera CRO, a TIGERMED Group Company完全的牙龈炎