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临床试验/NCT03214055
NCT03214055已完成不适用

Effect of Mannitol on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Radical Prostatectomy: a Prospective Observational Study

Asan Medical Center1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2017年7月12日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
39
试验地点
1
主要终点
Change in optic nerve sheath diameters

研究概览

简要总结

We aim to evaluate the change in optic nerve sheath diameters as a surrogate of intracranial pressure before and after mannitol administration in patients who undergo robot assisted laparoscopic radical prostatectomy with pneumoperitoneum and Trendelenburg position.

详细描述

Mannitol has been frequently used for renal protection during surgery. Optic nerve sheath diameter is used to evaluate intracranial pressure noninvasively. Robot-assisted laparoscopic radical prostatectomy can induce an increase in optic nerve sheath diameter due to Trendelenburg position and carbon dioxide insufflation. We therefore aim to evaluate the change in optic nerve sheath diameters before and after mannitol administration in patients who undergo robot assisted laparoscopic radical prostatectomy.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
20 Years 至 79 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • prostate cancer patients undergoing robot assisted laparoscopic radical prostatectomy.
  • 20 year old or above, 79 year old or below.
  • agreed to participate this study.

排除标准

  • history of cerebrovascular accident.
  • history of congestive heart failure.
  • history of pulmonary edema.
  • history of anaphylaxis to mannitol.
  • conversion to open prostatectomy.
  • combined with other operation.
  • inability to measure optic nerve sheath diameter.

结局指标

主要结局

Change in optic nerve sheath diameters

时间窗: 5 minutes after pneumoperitoneum and Trendelenburg position, 90 minutes after mannitol administration during pneumoperitoneum and Trendelenburg position

Change in optic nerve sheath diameters before and after mannitol administration

次要结局

  • Change in optic nerve sheath diameters(5 minutes after pneumoperitoneum and Trendelenburg position, 30 minutes after mannitol administration during pneumoperitoneum and Trendelenburg position)
  • Optic nerve sheath diameter(Intraoperative (during skin closure))

研究者

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

Young-Kug Kim

Professor

Asan Medical Center

研究点 (1)

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