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临床试验/NCT04224532
NCT04224532已完成不适用

The Effect of Pneumoperitoneum Timing on Intracranial Pressure in Laparoscopic Cholecystectomy: Before or After Reverse Trendelenburg Position

Bagcilar Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2020年1月8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
79
试验地点
2
主要终点
Change in Optic Nerve Sheath Diameter

研究概览

简要总结

Reverse Trendelenburg position has been shown to slightly reduce the intracranial pressure associated with pneumoperitoneum. However, there are no studies on the effect of the timing of reverse Trendelenburg position on intracranial pressure. This study will monitor the effect of reverse Trendelenburg position before or after pneumoperitoneum on intracranial pressure and regional cerebral oxygen saturation.

详细描述

The literature includes studies that investigate the relationship of pneumoperitoneum and different positions with intracranial pressure during laparoscopy. Reverse Trendelenburg position has been shown to slightly reduce the intracranial pressure associated with pneumoperitoneum. However, there are no studies on the effect of the timing of reverse Trendelenburg position on intracranial pressure. This study will monitor the effect of reverse Trendelenburg position before or after pneumoperitoneum on intracranial pressure and regional cerebral oxygen saturation. Ultrasound guided measurement of the optic nerve sheath diameter as a non-invasive method will be used for measurement. The investigators believe reverse Trendelenburg position before pneumoperitoneum may prevent undesired sudden increases in 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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Undergoing laparoscopic cholecystectomy operation
  • Age between 18-65

排除标准

  • Ophthalmologic disease and optic nerve pathology
  • Increased intracranial pressure
  • History of cerebrovascular disease

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 laparoscopic cholecystectomy among 6 time point.

Change in regional cerebral oxygen saturation

时间窗: Throughout the surgery

The change in regional cerebral oxygen saturation during laparoscopic cholecystectomy among 6 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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