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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06464419
Other study ID # 14408
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 10, 2024
Est. completion date September 1, 2024

Study information

Verified date June 2024
Source Basaksehir Çam & Sakura City Hospital
Contact Cansu Ekici
Phone +905322036054
Email cansugun00@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 52
Est. completion date September 1, 2024
Est. primary completion date August 10, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Intervention

Device:
ultrasound
Measurement of optic nerve sheath diameter by ultrasound

Locations

Country Name City State
Turkey EtlikCityHospital Ankara

Sponsors (2)

Lead Sponsor Collaborator
Basaksehir Çam & Sakura City Hospital Ankara Etlik City Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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 — View 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.JNS14 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Effect of lithotomy position on optic nerve sheath diameter In patients in the lithotomy position, the linear probe of the ultrasound will be placed on the patient's upper eyelid in a transverse and longitudinal manner without applying compression, and the optic nerve's entry into the orbit will be visualized and measured. The increase in the optic nerve sheath diameter will be recorded by measuring at 7 different times in total. Before general anesthesia (t1), 3 min (t2) and 5 min (t3) after general anesthesia, 3 min (t4) and 5 min (t5) after lithotomy position was given, before lithotomy position was corrected (t6) and when patients went to the recovery room (t7)
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