Effect of Pressure Regulation on Optic Nerve Sheath Diameter

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04339244

Enrollment

Registered

2020-04-09

Start date

2020-04-01

Completion date

2020-09-15

Last updated

2020-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Optic Nerve Sheath Diameter

Keywords

arterial pressure regulation

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

Interventions

OTHERRALRP under lower mean BP

RALRP under regulation of lower mean BP

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Prostate cancer receiving RALRP

Exclusion criteria

* glaucoma * intracranial tumor * previous disease elevating intracranial pressure

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026