Neural Damage and Anesthetic Treatment in the Preeclamptic Parturient; a Prospective Observational Cohort Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- NSE serum levels
研究概览
简要总结
Objectives: Our primary objective is to evaluate the effect of anesthetic method (general versus regional anesthesia) on neural outcomes in the preeclamptic population undergoing cesarean delivery. Secondary outcome is to examine the fetal cerebral outcomes associated with the anesthetic method.
Methodology: This prospective, observational study, will include 50 preeclamptic parturients undergoing cesarean section under general and regional anesthesia.
Neuron specific enolase and S100B Protein are neuronal injury biomarkers. Increased levels of these biomarkers in serum indicate neuron damage. Following enrollment venous blood will be drawn from the participants and assessed for NSE and S100B serum levels at the following points; Upon hospital admission and one day postpartum. Furthermore in order to evaluate fetal outcomes upon fetal delivery, umbilical cord blood will be examined for NSE and S100B.
Study significance: While spinal anesthesia is the preferred anesthetic method for the preeclamptic parturient undergoing cesarean delivery, it remains uncertain which anesthetic method is neuroprotective.
This study will be the first study, to our knowledge, to examine the effect of anesthetic method on neuronal outcomes for a parturient with preeclampsia undergoing cesarean delivery, by the use of noninvasive cerebral biomarkers.
详细描述
Scientific background:
Preeclampsia is an idiopathic maternal, multi organ, specific pregnancy disorder, associated with significant maternal and perinatal morbidity and mortality. Preeclampsia complicates approximately 2-8% of all pregnancies. The disorder is characterized by new-onset of hypertension and proteinuria developing after gestational week 20. While the pathogenesis of the disease remains not completely understood, a possible explanation is endothelial cell dysfunction in which placenta-derived mediators causes multisystem organ dysfunction .
Preeclampsia increases the risk for acute cerebrovascular complications such as intracerebral hemorrhage, cerebral edema and eclampsia. Treatment with magnesium sulfate reduces the risk for seizures and treatment with antihypertensive therapy reduces the risk for a stroke , however the only effective treatment for the syndrome is prompt delivery of the fetus .
When considering the optimal anesthetic method for a preeclamptic parturient undergoing cesarean delivery, neuraxial anesthetic techniques, when feasible, are strongly preferred to general anesthesia (GA) . Spinal anesthesia (SA) is favored over general anesthesia since it is associated with increased benefits and reduced risks compared with general anesthesia. Increased benefits of SA include higher patient satisfaction, decreased pain and favorable neonatal outcomes. GA has been associated with increased risk for aspiration, unstable hemodynamics and difficult airway management . In addition GA has been shown to increase the risk for a stroke in women with preeclampsia . Nevertheless GA is sometime used in the preeclamptic parturient due to maternal or fetal indications with an incidence as high as 44% in some European countries .
Accumulative evidence from animal studies indicate that general anesthetic agents are neurotoxic and can induce subsequent behavioral abnormalities in the developmental mind . However the fetal and pediatric implications remain inconclusive. In a population-based birth cohort study fetal exposure to general anesthesia during cesarean delivery was not associated with increased risk for learning disabilities compared to delivering vaginally . In contrast in a population-based birth cohort study conducted in Taiwan the incidence of autism was increased in neonates who were delivered by cesarean delivery under general anesthesia compared with regional anesthesia .
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 60 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Fifty preeclamptic parturients age 18 and above presenting for cesarean delivery under SA or GA, with ability to comply with study requirements will be enrolled in the study.
排除标准
- •The following parturients will be excluded:
- •Parturients under age 18
- •Parturients undergoing a vaginal delivery.
- •Parturients unable to sign an informed consent forum.
结局指标
主要结局
NSE serum levels
时间窗: 1 Day postpartum
Maternal serum NSE levels after delivery in both study groups
S100 B protein
时间窗: 1 Day postpartum
Maternal serum S100B levels after delivery in both study groups. Maternal serum NSE levels after delivery in both study groups
次要结局
- Fetal serum S100b levels(At delivery)
- Fetal serum NSE levels(At delivery)
