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临床试验/NCT05185908
NCT05185908已完成不适用

The Effects of Lateral 45° Downward Position and Carbon Dioxide Pneumoperitoneum on the Optic Nerve Sheath Diameter in Patients Undergoing Laparoscopic Transperitoneal Nephrectomies: A Prospective Observational Study

Istanbul University0 个研究点目标入组 26 人开始时间: 2016年12月1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
26
主要终点
optic nerve sheath diameter

研究概览

简要总结

Trendelenburg position and carbon dioxide (CO2) pneumoperitoneum are in association with increased intracranial pressure (ICP) reflected by the optic nerve sheath diameter (ONSD). Measurement of ONSD by ultrasound (US) guidance can be used in the diagnosis of ICP. The investigators interrogated the effects of lateral 45° downward position and CO2 insufflation on ONSD in patients undergoing laparoscopic transperitoneal nephrectomy.

详细描述

Transperitoneal laparoscopic nephrectomy is a popular and increasingly used alternative to the laparoscopic retroperitoneal approach because of benefits such as minimal invasion, the transperitoneal path provides a larger working space and familiar anatomic landmarks. This technique requires a steep (35° to 45°) lateral downward (SLD) position and a CO2 pneumoperitoneum. SLD may lead to pathophysiological changes such as pulmonary dysfunction with the formation of atelectasis and increasing airway pressure as well as ocular complications. These are firstly reported 2 patients with bilateral ischaemic optic neuropathy (ION) after a da Vinci robotic-assisted procedure. SLD has raised concerns that prolonged elevation of venous pressure in the head may increase the risk of developing ION. However, a few investigations have yet been made into intraoperative changes in intraocular pressure (IOP) and optic nerve sheath diameter (ONSD) - correlating with intracranial pressure (ICP) - and their adverse ocular effects. The operative conditions get better the steeper the positioning, providing an excellent intraabdominal view and probably less bleeding. The hypothesis of the study is that patients placed in SLD for several hours have a high risk for ocular changes and peri- and postoperative complications. The aim of this study was to investigate the influence of capnoperitoneum and permanent 45° SLD on IOP and ONSD in patients undergoing laparoscopic transperitoneal nephrectomy. The investigators also analyzed the hemodynamic and respiratory parameters, duration of surgery during laparoscopic nephrectomy. Perioperative and postoperative complications were also recorded.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients older than 18 years who have undergone laparoscopic transperitoneal nephrectomy.

排除标准

  • Those who have neurological and cerebrovascular disease.

结局指标

主要结局

optic nerve sheath diameter

时间窗: up to 24 hours

Measurement of optic nerve sheath diameter by ultrasound (US) guidance can be used in the diagnosis of increased intracranial pressure (ICP).

次要结局

  • Respiratory parameters(up to 24 hours)
  • Hemodynamic parameters(up to 24 hours)

研究者

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

Meltem Savran Karadeniz

Associate Professor

Istanbul University

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