Effect of Pressure Regulation on Optic Nerve Sheath Diameter

October 10, 2020 updated by: Ji Hee Hong, Keimyung University Dongsan Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Prostate cancer receiving RALRP

Exclusion Criteria:

  • glaucoma
  • intracranial tumor
  • previous disease elevating intracranial pressure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keimyung University Dongsan Medical Center

Investigators

  • Study Director: Sung Won Jung, PhD, 82532584892

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Actual)

August 15, 2020

Study Completion (Actual)

September 15, 2020

Study Registration Dates

First Submitted

April 6, 2020

First Submitted That Met QC Criteria

April 6, 2020

First Posted (Actual)

April 9, 2020

Study Record Updates

Last Update Posted (Actual)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 10, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2019-07-049

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Optic Nerve Sheath Diameter

Clinical Trials on RALRP under lower mean BP

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe