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临床试验/NCT04095832
NCT04095832已完成不适用

The Effect of Epidural Anesthesia on the Optic Nerve Sheath Diameter in Preeclampsia: A Prospective Observational Study

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2020年4月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
Optic nerve sheath diameter (ONSD) after epidural anesthesia

研究概览

简要总结

This study aims to assess the effect of epidural anesthesia on the optic nerve sheath diameter in parturients with preeclampsia.

详细描述

This prospective observational study will be performed in parturients, either with or without preeclampsia, who scheduled to undergo elective cesarean delivery under epidural anesthesia. Epidural anesthesia will be done according to the standard technique. Optic nerve sheath diameter (ONSD) will be measured before and after the epidural injection of anesthetic solutions using ultrasonography. The investigators will assess whether epidural anesthesia has effect on optic nerve sheath diameter of pregnant women, and the investigators will also compare ONSD between healthy parturients and parturients with preeclampsia. The investigators will evaluate the relationship between ONSD and disease severity of preeclampsia.

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
19 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients scheduled to undergo planned cesarean section under epidural anesthesia if they have a singleton pregnancy, complicated by severe preeclampsia.
  • Severe preeclampsia was defined using the American College of Obstetricians and Gynecologist Task Force on Hypertension in Pregnancy recommendations
  • Controls will be healthy pregnant women at term (>37 weeks), with a singleton pregnancy, no signs or symptoms of preeclampsia and no intrauterine fetal growth restriction, who are planned to undergo elective cesarean delivery under epidural anesthesia

排除标准

  • Contraindication to epidural anesthesia
  • Morbid cardiovascular disease
  • Cerebrovascular disease
  • Known fetal anomaly
  • Any signs of onset of labor
  • Body weight < 40 kg or body weight > 100 kg
  • Height < 140cm or height > 190cm
  • eye disease
  • infection or trauma near the eyes
  • abnormality of intracranial pressure due to Intracranial pathology

结局指标

主要结局

Optic nerve sheath diameter (ONSD) after epidural anesthesia

时间窗: 3 minutes after the completion of epidural injection of the anesthetic solutions

measured by transocular ultrasonography

次要结局

  • eclampsia(during the admission period)
  • intracranial hemorrhage(during the admission period)
  • Umbilical arterial PO2(immediately after delivery)
  • Epigastric pain(during the admission period)
  • Serum creatinine(during the admission period)
  • Apgar Score of fetus(at 1 min, 5 min)
  • ALT(during the admission period)
  • Optic nerve sheath diameter (ONSD)(before epidural anesthesia, 10, 20 minutes after the completion of epidural injection of the anesthetic solutions, 10 minutes after delivery of fetus, at the end of surgery.)
  • Blood pressure(on delivery day)
  • Proteinuria(during the admission period)
  • Headache(during the admission period)
  • Visual disturbances(during the admission period)
  • Oliguria(during the admission period)
  • Serum albumin(during the admission period)
  • Platelet count(during the admission period)
  • AST(during the admission period)
  • Umbilical arterial pH(immediately after delivery)
  • Umbilical arterial PCO2(immediately after delivery)
  • Umbilical arterial base excess(immediately after delivery)

研究者

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

Jin-Tae Kim

Professor

Seoul National University Hospital

研究点 (1)

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