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

NCT03691025 | Unknown

• 1 other identifier: hacetteperobotprostat
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Elevated Intracranial Pressure; Optic Nerve Sheath Diameter; ONSD /ETD Ratio

Keywords

robot assisted laparoscopic prostatectomy; optic nerve sheath diameter

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

RALPD

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients referred to Hacettepe University Department of Urology

You may qualify if:

• years patients undergoing RALP

You may not qualify if:

• a history of corneal surgery, open-angle or closed-angle glaucoma
• intraocular surgery
• history of elevated ICPs

Sponsors & Collaborators

• Hacettepe University: lead

Related 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.

  PMID: 29162911 RESULT

MeSH Terms

Conditions

Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Başak Akça

  Hacettepe University Department of Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Başak Akça

CONTACT

00905322275451; drbasakakca@gmail.com

Banu Kılıçaslan

CONTACT

00905322969290; banuk09oct@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist.Prof

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 1, 2018
• Study Start: October 15, 2018
• Primary Completion: February 15, 2019
• Study Completion: March 1, 2019
• Last Updated: October 2, 2018

Record last verified: 2018-09