Effect of Pressure Regulation on Optic Nerve Sheath Diameter

NCT ID: NCT04339244

Last Updated: 2020-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2020-09-15

Brief 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.

Detailed 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

Conditions

Optic Nerve Sheath Diameter

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ONSD measurement under lower blood pressure

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

Group Type: ACTIVE_COMPARATOR

RALRP under lower mean BP

Intervention Type: OTHER

RALRP under regulation of lower mean BP

ONSD measurement under highly normal blood pressure

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

Group Type: ACTIVE_COMPARATOR

RALRP under lower mean BP

Intervention Type: OTHER

RALRP under regulation of highly normal mean BP

Interventions

RALRP under lower mean BP

RALRP under regulation of lower mean BP

Intervention Type: OTHER

RALRP under lower mean BP

RALRP under regulation of highly normal mean BP

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Prostate cancer receiving RALRP

Exclusion Criteria

• glaucoma
• intracranial tumor
• previous disease elevating intracranial pressure

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Keimyung University Dongsan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ji Hee Hong

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sung Won Jung, PhD

Role: STUDY_DIRECTOR

82532584892

Locations

Hong ji HEE

Daegu, , South Korea

Countries

South Korea

Other Identifiers

2019-07-049

Identifier Type: -

Identifier Source: org_study_id