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

Optic Nerve Sheath Diameter Clinical Trial

Official title:

Ultrasonographic Measurement of the Optic Nerve Sheath Diameter and Its Association With Eyeball Transverse Diameter in Robot-assisted Laparoscopic Radical Prostatectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03691025
• Other study ID #: hacetteperobotprostat
• Status: Not yet recruiting
• Start date: October 15, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: September 2018
• Source: Hacettepe University
• Contact: Basak Akça
• Phone: 00905322275451
• Email: drbasakakca[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 1, 2019
• Est. primary completion date: February 15, 2019
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Elevated Intracranial Pressure
• Intracranial Hypertension
• ONSD /ETD Ratio
• Optic Nerve Sheath Diameter

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

References & Publications (1)

Kim DH, Jun JS, Kim R. Ultrasonographic measurement of the optic nerve sheath diameter and its association with eyeball transverse diameter in 585 healthy volunteers. Sci Rep. 2017 Nov 21;7(1):15906. doi: 10.1038/s41598-017-16173-z. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association of the Optic Nerve Sheath Diameter With Eyeball Transverse Diameter in Robot-assisted Prostatectomy	To determine a cut off value for ratio of ONSD to ETD in a group known to have elevated ICPs	6 months