Skip to main content
OpenTrials
Completed

NCT Number: NCT04339244

Effect of Pressure Regulation on Optic Nerve Sheath Diameter

Intracranial pressure is known to increase during robot-assisted laparoscopic radical prostatectomy (RALRP) due to steep trendelenberg position. Measurement of optic nerve sheath diameter (ONSD) is a indirect method which can assess the degree of intracranial pressure.

This study is designed to measure the ONSD during RALRP under regulation of arterial pressure.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Optic Nerve Sheath Diameter

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hong ji HEE

Daegu, 42601, South Korea

About this study

During last decades, RALRP has been advocated due to the advantages of short hospital stay, reduced blood loss during surgery, less postoperative pain and complication. During RALRP, steep trendelenberg postion and pneumoperitoneum are required essentially, and this is for the acquisition of adequite surgical field. However, such position and pneumoperitoneum can result in harmful hemodynamic change. Previous study demonstrated that patients of RALRP showed 12.5% increase of ONSD.

The relationship of ONSD and increase of intracranial pressure has been proved previously through many studies. Recent meta analysis showed that ONSD measurement for the monitor of ICP demonstrated that sensitivity 0.9, specificity 0.85 and ROC cuve 0.983.

In addition, increase of ONSD during RALRP can be affected by the degree of arterial pressure and end tidal CO2 increase.

This study is designed to see the effect of arterial pressure regulation on the increase of ONSD

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Prostate cancer receiving RALRP

Exclusion criteria

  • glaucoma
  • intracranial tumor
  • previous disease elevating intracranial pressure

Treatment and study plan

RALRP under lower mean BP

Other

RALRP under regulation of lower mean BP

Primary outcomes

  1. optic nerve sheath diameter change among 4 time period

    Time frame: Baseline, 1 hour, 2 hours, 2.5 hours after completion of the intervention

    optice nerve sheath diameter change among 4 time period

Sponsors and collaborators

Lead sponsor

Keimyung University Dongsan Medical Center

Other

Registry information

Official study title

Effect of Arterial Pressure Regulation on Optic Nerve Sheath Diameter During Robot Assisted Laparoscopic Surgery

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 9, 2020
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.