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RecruitingNCT06464419Updated Aug 5, 2024

Effect of Lithotomy Position on Optic Nerve Sheath Diameter

An observational study in Optic Nerve Cup and Intracranial Pressure Increase, sponsored by Başakşehir Çam & Sakura City Hospital. Recruiting at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-05.

Sponsored by Başakşehir Çam & Sakura City Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 1 month ago, but the record still lists the study as recruiting.
  • Started Jun 2024; still recruiting 2 years 3 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
52
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Optic Nerve Cup
  • Intracranial Pressure Increase

Keywords

  • ultrasonography, lithotomy position
03

In context

Intracranial Hypertension

185 studies on the registry are indexed under Intracranial Hypertension; 45 are open to participants now.

This study's planned enrollment of 52 is below the median of 60 across 80 observational studies indexed under Intracranial Hypertension.

Browse Intracranial Hypertension studies →

Lead sponsor

Başakşehir Çam & Sakura City Hospital is the lead sponsor of 105 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
52 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients who will undergo RIRS surgery

    Patients who will undergo RIRS surgery in the lithotomy position

    Device: ultrasound

Interventions

  • Deviceultrasound

    Measurement of optic nerve sheath diameter by ultrasound

06

What researchers measure

Primary outcomes

  1. 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 minutes (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 10 minutes after patients go to the recovery room (t7).

    Time frame: intraoperative and postoperative 10 minutes

07

Study locations

1 of 1 sites recruiting
  • EtlikCityHospital
    Ankara, Turkey
    Recruiting
08

References and documents

Publications

  • 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. PubMed 25955869 ↗
  • 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. PubMed 30384564 ↗
  • 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. PubMed 28284189 ↗

Individual participant data

Plan to share: Undecided — Not decided yet

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06464419
Lead sponsor
Başakşehir Çam & Sakura City Hospital
Collaborators
Ankara Etlik City Hospital
Responsible party
Sponsor
First posted
Jun 18, 2024
Start date
Jun 10, 2024
Primary completion
Aug 10, 2024 (estimated)
Completion
Sep 1, 2024 (estimated)
Last update
Aug 5, 2024

Study contacts

Cansu Ekici
Contact
cansugun00@gmail.com
+905322036054
Cansu Ekici
study director · EtlikCityHospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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