Effect of Pressure Regulation on Optic Nerve Sheath Diameter

Optic Nerve Sheath Diameter Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04339244
• Other study ID #: 2019-07-049
• Status: Completed
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: September 15, 2020

Study information

• Verified date: October 2020
• Source: Keimyung University Dongsan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: September 15, 2020
• Est. primary completion date: August 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• Prostate cancer receiving RALRP

Exclusion Criteria:

• glaucoma

• intracranial tumor

• previous disease elevating intracranial pressure

Related Conditions & MeSH terms

• Optic Nerve Sheath Diameter

Intervention

Other:
• RALRP under lower mean BP
RALRP under regulation of lower mean BP
• RALRP under lower mean BP
RALRP under regulation of highly normal mean BP

Locations

Country	Name	City	State
Korea, Republic of	Hong ji HEE	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Keimyung University Dongsan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	optic nerve sheath diameter change among 4 time period	optice nerve sheath diameter change among 4 time period	Baseline, 1 hour, 2 hours, 2.5 hours after completion of the intervention