跳至主要内容
临床试验/NCT03691025
NCT03691025Unknown不适用

Ultrasonographic Measurement of the Optic Nerve Sheath Diameter and Its Association With Eyeball Transverse Diameter in Robot-assisted Laparoscopic Radical Prostatectomy

Hacettepe University0 个研究点目标入组 60 人开始时间: 2018年10月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
主要终点
Association of the Optic Nerve Sheath Diameter With Eyeball Transverse Diameter in Robot-assisted Prostatectomy

研究概览

简要总结

Robot-assisted laparoscopic radical prostatectomy (RALRP) is becoming a popular procedure due to its unique advantages.

Despite these advantages, pneumoperitoneum and steep trendelenburg position are associated with hemodynamic instability and elevated intracranial pressures (ICP).

Ultrasonographic measurement of optic nerve sheath diameter (ONSD) is an indirect but also a generally accepted reliable and noninvasive measurement of elevated ICP. However, optimal cut-off values are highly inconsistent due to multiple factors (gender, height, weight). To eliminate the effects of these factors on the results; a ratio should be established in patients known to have elevated ICPs.

In a recent study ONSD/ eyeball transverse diameter(ETD) in healthy volunteers in a specific population was established.

60 patients without any history of ICP undergoing RALRP will be enrolled to the study. Ultrasonographic measurement of ONSD and ETD will be performed 10 minutes after induction of general anesthesia, 10 minutes after CO2 pneumoperitoneum with trendelenburg positioning and measurements will be repeated hourly and at last after returning to supine position without CO2 pneumoperitoneum at the end of the procedure.

Hemodynamic variables and BIS values on this specific times will be recorded and an arterial sample will be obtained.

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
18 Years 至 75 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 19-75 years patients undergoing RALP

排除标准

  • a history of corneal surgery, open-angle or closed-angle glaucoma
  • intraocular surgery
  • history of elevated ICPs

结局指标

主要结局

Association of the Optic Nerve Sheath Diameter With Eyeball Transverse Diameter in Robot-assisted Prostatectomy

时间窗: 6 months

To determine a cut off value for ratio of ONSD to ETD in a group known to have elevated ICPs

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

Başak Akça

Assist.Prof

Hacettepe University

相似试验