Clinical trial NCT06464419: Effect of Lithotomy Position on Optic Nerve Sheath Diameter
Official title: Ultrasonographic Evaluation of Optic Nerve Sheath Diameter in Patients Undergoing Retrograde Intrarenal Surgery in the Lithotomy Position
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Optic Nerve Cup
Intracranial Pressure Increase
Keywords: ultrasonography, lithotomy position
Lead sponsor: Başakşehir Çam & Sakura City Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Ankara Etlik City Hospital
First posted: 2024-06-18
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 52 patients, ASA I-II, aged between 18-65, who are scheduled for elective RIRS surgery under general anesthesia will be included.

Brief summary: In this study, the effect of increased venous return and increased intra-abdominal pressure on intracranial pressure in the lithotomy position was evaluated.

Detailed description: In the lithotomy position, it is possible that venous return in the lower extremities increases and intra-abdominal pressure increases due to the position. At the same time, it is possible that the intracompartmental pressure in the extremities increases because the venous structure is compressed by placing the lower extremities on supports. Considering both conditions, it is predicted that there may be an increase in the optic nerve sheath diameter due to increased intracranial pressure in patients placed in the lithotomy position. The aim of this study is to investigate the effect of the position on intracranial pressure by ultrasonographically evaluating the optic nerve sheath diameter in the lithotomy position.

Eligibility criteria: Inclusion Criteria:

* Patients who give informed consent
* Patients who will undergo retrograde intrarenal surgery
* Patients who are fully oriented and cooperative
* ASA I-II patients
* Patients between the ages of 18-65

Exclusion Criteria:

* Disoriented and uncooperative patients
* Patients with BMI\>30
* Patients who have had previous intracranial surgery
* Patients who have had eye surgery before
* Patients allergic to the pharmacological agents used in the study

Primary outcomes:
measure: Effect of lithotomy position on optic nerve sheath diameter
timeFrame: intraoperative and postoperative 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: EtlikCityHospital
Study officials:
affiliation: EtlikCityHospital
name: Cansu Ekici
role: STUDY_DIRECTOR
References:
citation: Maissan IM, Dirven PJ, Haitsma IK, Hoeks SE, Gommers D, Stolker RJ. Ultrasonographic measured optic nerve sheath diameter as an accurate and quick monitor for changes in intracranial pressure. J Neurosurg. 2015 Sep;123(3):743-7. doi: 10.3171/2014.10.JNS141197. Epub 2015 May 8.
citation: Besir A, Tugcugil E. Effects of tourniquet usage in lower extremity surgery on optic nerve sheath diameter. Turk J Med Sci. 2018 Oct 31;48(5):980-984. doi: 10.3906/sag-1803-132.
citation: Blecha S, Harth M, Schlachetzki F, Zeman F, Blecha C, Flora P, Burger M, Denzinger S, Graf BM, Helbig H, Pawlik MT. Changes in intraocular pressure and optic nerve sheath diameter in patients undergoing robotic-assisted laparoscopic prostatectomy in steep 45 degrees Trendelenburg position. BMC Anesthesiol. 2017 Mar 11;17(1):40. doi: 10.1186/s12871-017-0333-3.