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临床试验/NCT03536910
NCT03536910已完成不适用

Evaluation of Copeptin Levels in Elective Cesarean Section With Spinal and General Anesthesia and Their Relationship With Fetal Stress: Prospective Study

Istanbul University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Changes in copeptin levels after general or spinal anesthesia

研究概览

简要总结

In this study, investigators aimed to investigate the effects of general and spinal anesthesia techniques on copeptin levels during cesarean section and their relation with fetal distress.

详细描述

During the delivery process, the mother and the baby generate some endocrine responses to this emotional and physical stressful action. Arginin-Vasopressin prohormone (copeptin), which is more stable and measurable in blood, is used as an endogenous stress indicator. Copeptin levels have been shown to be significantly increased in vaginally delivery when compared to cesarean section (c / s). In a caesarean section; it is a known fact that when the general anesthetic method and the used anesthetic substances are taken into consideration, it gives a significant stress to the mother and the baby. Spinal anesthesia with no impaired fetal oxygenation and without orotracheal intubation and neuromuscular blockers may reduce fetal distress. However, there was no study investigating the effect of the anesthesia techniques in elective cesarean section on the fetal stress and the level of copeptin, in the literature review. Therefore investigators aimed to compare spinal and general anesthesia technique in elective cesarean section, to evaluate level of copeptin and their relation with fetal distress.Investigators hope that this study will guide the anesthesia method that can be chosen primarily in caesarean section.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 18-40 years of age
  • 36-40 gestational weeks
  • Undergoing elective cesarean section

排除标准

  • Coagulopathy
  • Known central or peripheral nerve disease
  • fetal anomalies
  • birth weight less than 2000 grams and above 4500 grams,
  • infants with a risk of meconium or amniotic fluid aspiration
  • kidney failure, diabetes mellitus, hypertension, cardiac disease, antepartum hemorrhage, asthma bronchiole, Rh incompatibility, congenital malformations

研究组 & 干预措施

General anesthesia

Other

干预措施: Copeptin (Other)

Spinal anesthesia

Other

干预措施: Copeptin (Other)

结局指标

主要结局

Changes in copeptin levels after general or spinal anesthesia

时间窗: Baseline and immediately after surgery from maternal blood and arterial and venous umbilical cord at birth

次要结局

未报告次要终点

研究者

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

Ece YAMAK ALTINPULLUK

Principal Investigator

Istanbul University

研究点 (2)

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