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临床试验/NCT04446013
NCT04446013已完成不适用

Comparison of Optic Nerve Sheath Diameter and Cerebral Regional Oxygen Saturation Measurements Between General and Spinal Anesthesia Applications in C-Section

Bagcilar Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2020年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
81
试验地点
2
主要终点
Change in Optic Nerve Sheath Diameter

研究概览

简要总结

General anesthesia and regional anesthesia can be chosen in cesarean operations. Endotracheal intubation and mechanical ventilation are components of general anesthesia. Endotracheal intubation has been shown to cause increased intracranial pressure. There is not enough information about the effect of spinal anesthesia on intracranial pressure during cesarean operations. Increased intracranial pressure can cause neurological complications by disrupting brain perfusion. For this reason, the investigators think that the safe anesthesia method should be determined especially in pregnant patients who are at risk of increased intracranial pressure.

研究设计

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

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Undergoing elective c-section operation
  • Age between 18-49
  • Gestational week ≥ 36

排除标准

  • Ophthalmologic disease and optic nerve pathology
  • Increased intracranial pressure
  • History of cerebrovascular disease
  • Cases where spinal anesthesia is contraindicated
  • Emergency cesarean category level 1

结局指标

主要结局

Change in Optic Nerve Sheath Diameter

时间窗: Throughout the surgery

The change in intracranial pressure via optic nerve sheath diameter measurement during c-section among 5 time point.

Change in regional cerebral oxygen saturation

时间窗: Throughout the surgery

The change in regional cerebral oxygen saturation during c-section among 5 time point.

次要结局

  • Perioperative Hemodynamic Parameters(Throughout the surgery)

研究者

发起方
Bagcilar Training and Research Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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