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

NCT03691025 · Hacettepe University · Updated 2 Oct 2018

What is being tested
Not stated
For
Elevated Intracranial Pressure; Optic Nerve Sheath Diameter; ONSD /ETD Ratio
Kind of study
Watches patients without assigning a treatment. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 75 years. About 60 people. The full rules are on the registry page.
Where
Not stated
When
Starts or started 15 Oct 2018, ends 1 March 2019. Registered 1 Oct 2018.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT03691025