Effect of Pressure Regulation on Optic Nerve Sheath Diameter

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Optic Nerve Sheath Diameter

Intervention / Treatment
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* Other: RALRP under lower mean BP
* Other: RALRP under lower mean BP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prostate cancer receiving RALRP Exclusion Criteria: glaucoma intracranial tumor previous disease elevating intracranial pressure

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ONSD measurement under lower blood pressure<br>ONSD measurement under mean blood pressure of 60 70 mmHg | Other: RALRP under lower mean BP<br>* RALRP under regulation of lower mean BP<br>|
| Active Comparator: ONSD measurement under highly normal blood pressure<br>ONSD measurement under mean blood pressure of 90 100 mmHg | Other: RALRP under lower mean BP<br>* RALRP under regulation of highly normal mean BP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arterial pressure regulation