跳至主要内容
临床试验/CTRI/2025/07/091632
CTRI/2025/07/091632
尚未招募
不适用

A prospective observational study of the effect of steep trendelenburg position on intraocular pressure and optic merve sheath diameter in robotic surgery at SMS Medical College, Jaipur.

SMS Medical College and Attached HospitalsJAIPR1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2025年8月15日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
SMS Medical College and Attached HospitalsJAIPR
入组人数
35
试验地点
1
主要终点
1.To assess the effect of steep trendelenburg position on optic nerve sheath diameter and intraocular pressure.

概览

简要总结

Surgery has shifted from open procedures to minimally invasive techniques, with robotic surgery leading the charge with its precision , improved visualization and faster recovery times.

The human eye relies on a delicate balance of pressure for proper function. High intraocular pressure increases the risk of glaucoma and change in optic nerve sheath diameter by USG can indicate pressure problems.

Understanding how minimally invasive surgery affects intraocular pressure and optic nerve sheath diameter is crucial for patient safety, as some techniques like Trendelenburg position, co2 insufflation might theoretically influence both.

Robot assisted laparoscopic prostatectomy is a prime example, offering advantages but raising concern about its impact on intraocular pressure and optic nerve sheath diameter.

The Trendelenburg position used during Robotic surgery might elevate IOP and co2 insufflation could potentially affect blood flow impacting IOP.

This study is planned to observe the impact of ROBOT assisted laparoscopic prostatectomy on IOP and optic nerve sheath diameter by USG to understand its effects on the eye.

研究设计

研究类型
Observational

入排标准

年龄范围
50.00 Year(s) 至 75.00 Year(s)(—)
性别
Male

入选标准

  • 1.Patient diagnosed with prostate cancer requiring surgery.2.Patient scheduled for Robot assisted laparoscopic prostatectomy.
  • 3.Patients meets age criteria, 50 to 75 years.
  • 4.Patients giving informed and written consent after understanding risks and benefits.

排除标准

  • 1.Patient should not be part of any other study.
  • 2.Pre existing glaucoma or significant eye issues.
  • 3.Uncontrolled hypertension or other severe medical conditions.
  • 4.Patients with anesthetic contraindications for Robot assisted laparoscopic prostatectomy.

结局指标

主要结局

1.To assess the effect of steep trendelenburg position on optic nerve sheath diameter and intraocular pressure.

时间窗: 1.To assess the effect of steep trendelenburg positions and co2 insufflation on optic nerve sheath diameter in mm and IOP in mmHg. | 2.To assess and compare the correlation between IOP and optic nerve sheath diameter. | 3.To assess the hemodynamic parameters.

2.To assess and compare the correlation between Intraocular pressure and optic nerve sheath diameter.

时间窗: 1.To assess the effect of steep trendelenburg positions and co2 insufflation on optic nerve sheath diameter in mm and IOP in mmHg. | 2.To assess and compare the correlation between IOP and optic nerve sheath diameter. | 3.To assess the hemodynamic parameters.

3.To assess the hemodynamic parameters.

时间窗: 1.To assess the effect of steep trendelenburg positions and co2 insufflation on optic nerve sheath diameter in mm and IOP in mmHg. | 2.To assess and compare the correlation between IOP and optic nerve sheath diameter. | 3.To assess the hemodynamic parameters.

次要结局

  • To assess the side effect & complications if any , post operative vision loss.(Postoperative)

研究者

发起方
SMS Medical College and Attached HospitalsJAIPR
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Varsha Kothari

SMS Medical college, Jaipur

研究点 (1)

Loading locations...

相似试验