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Association of the Optic Nerve Sheath Diameter With Eyeball Transverse Diameter in Robot-assisted Prostatectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03691025
Recruitment Status : Unknown
Verified September 2018 by Başak Akça, Hacettepe University.
Recruitment status was:  Not yet recruiting
First Posted : October 1, 2018
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Başak Akça, Hacettepe University

Study Description
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Brief Summary:

Robot-assisted laparoscopic radical prostatectomy (RALRP) is becoming a popular procedure due to its unique advantages.

Despite these advantages, pneumoperitoneum and steep trendelenburg position are associated with hemodynamic instability and elevated intracranial pressures (ICP).

Ultrasonographic measurement of optic nerve sheath diameter (ONSD) is an indirect but also a generally accepted reliable and noninvasive measurement of elevated ICP. However, optimal cut-off values are highly inconsistent due to multiple factors (gender, height, weight). To eliminate the effects of these factors on the results; a ratio should be established in patients known to have elevated ICPs.

In a recent study ONSD/ eyeball transverse diameter(ETD) in healthy volunteers in a specific population was established.

60 patients without any history of ICP undergoing RALRP will be enrolled to the study. Ultrasonographic measurement of ONSD and ETD will be performed 10 minutes after induction of general anesthesia, 10 minutes after CO2 pneumoperitoneum with trendelenburg positioning and measurements will be repeated hourly and at last after returning to supine position without CO2 pneumoperitoneum at the end of the procedure.

Hemodynamic variables and BIS values on this specific times will be recorded and an arterial sample will be obtained.


Condition or disease
Elevated Intracranial Pressure Optic Nerve Sheath Diameter ONSD /ETD Ratio

Study Design
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ultrasonographic Measurement of the Optic Nerve Sheath Diameter and Its Association With Eyeball Transverse Diameter in Robot-assisted Laparoscopic Radical Prostatectomy
Estimated Study Start Date : October 15, 2018
Estimated Primary Completion Date : February 15, 2019
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
RALPD


Outcome Measures
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Primary Outcome Measures :
  1. Association of the Optic Nerve Sheath Diameter With Eyeball Transverse Diameter in Robot-assisted Prostatectomy [ Time Frame: 6 months ]
    To determine a cut off value for ratio of ONSD to ETD in a group known to have elevated ICPs


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Sampling Method:   Probability Sample
Study Population
patients referred to Hacettepe University Department of Urology
Criteria

Inclusion Criteria:

  • 19-75 years patients undergoing RALP

Exclusion Criteria:

  • a history of corneal surgery, open-angle or closed-angle glaucoma
  • intraocular surgery
  • history of elevated ICPs
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03691025


Contacts
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Contact: Başak Akça 00905322275451 drbasakakca@gmail.com
Contact: Banu Kılıçaslan 00905322969290 banuk09oct@gmail.com

Sponsors and Collaborators
Hacettepe University
Investigators
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Principal Investigator: Başak Akça Hacettepe University Department of Anesthesiology and Reanimation
More Information
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Publications of Results:

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Responsible Party: Başak Akça, Assist.Prof, Hacettepe University
ClinicalTrials.gov Identifier: NCT03691025    
Other Study ID Numbers: hacetteperobotprostat
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Başak Akça, Hacettepe University:
robot assisted laparoscopic prostatectomy
optic nerve sheath diameter
Additional relevant MeSH terms:
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Intracranial Hypertension
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases