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

NCT ID: NCT03691025

Last Updated: 2018-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-15

Study Completion Date

2019-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Elevated Intracranial Pressure Optic Nerve Sheath Diameter ONSD /ETD Ratio

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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RALPD

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Başak Akça

Assist.Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Başak Akça

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University Department of Anesthesiology and Reanimation

Central Contacts

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Başak Akça

Role: CONTACT

00905322275451

Banu Kılıçaslan

Role: CONTACT

00905322969290

References

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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.

Reference Type RESULT
PMID: 29162911 (View on PubMed)

Other Identifiers

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hacetteperobotprostat

Identifier Type: -

Identifier Source: org_study_id

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