Effect of Pressure Regulation on Optic Nerve Sheath Diameter

Keimyung University

Status: Completed

Conditions: Optic Nerve Sheath Diameter

Treatments: Other: RALRP under lower mean BP

Study type: Interventional

Funder types: Other

Identifiers

NCT04339244

2019-07-049

Details and patient eligibility

About

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.

Full 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

Enrollment: 51 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Prostate cancer receiving RALRP

Exclusion criteria

• glaucoma
• intracranial tumor
• previous disease elevating intracranial pressure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 2 patient groups

ONSD measurement under lower blood pressure

Active Comparator group

Description:

ONSD measurement under mean blood pressure of 60\~70 mmHg

Treatment:

Other: RALRP under lower mean BP

Other: RALRP under lower mean BP

ONSD measurement under highly normal blood pressure

Active Comparator group

Description:

ONSD measurement under mean blood pressure of 90\~100 mmHg

Treatment:

Other: RALRP under lower mean BP

Other: RALRP under lower mean BP