Clinical trial Recruiting at 1 site Observational Ages 18 and up Men only

Head-down position and abdominal gas effects on optic nerve sheath size during robotic prostate removal

Official title: Effect of Steep Trendelenburg Position and Pneumoperitoneum on Optic Nerve Sheath Diameter in Robot-Assisted Laparoscopic Radical Prostatectomy: A Prospective Study

Run by Ege University · NCT07491198 · Data updated 2026-11-12

This will see if the steep head-down position and abdominal gas used during robot-assisted prostate removal increase the optic nerve sheath diameter in men having prostatectomy.

Quick facts

Study typeObservational
Ages18 Years and up
SexMen only
Enrollment50 (estimated)
SponsorEge University
Academic / other
Locations1 site (Izmir, İzmir)
StatusRecruiting
StartedJanuary 5, 2026
Main results expectedOctober 1, 2026
Study endsDecember 2026
Registry record updatedSeptember 10, 2026
Trial IDNCT07491198 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adult men (≥18 years) scheduled for robot-assisted or open radical prostatectomy under general anesthesia with ASA physical status I–III, no prior intracranial or significant ocular disease, and able to give informed consent.

Probably not a fit

Patients with prior intracranial surgery, known ocular disease, very high intraocular pressure, or those not undergoing prostatectomy are unlikely to benefit directly from this study's findings.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational study will measure optic nerve sheath diameter by ocular ultrasound at predefined time points before, during, and after surgery in patients undergoing robot-assisted laparoscopic radical prostatectomy and in a comparison group undergoing open radical prostatectomy. Intraoperative hemodynamic and respiratory variables, intra-abdominal pressure, blood loss, fluid administration, and surgery duration will be recorded to correlate physiological changes with optic nerve sheath measurements. The aim is to determine whether pneumoperitoneum and steep Trendelenburg positioning produce measurable increases in optic nerve sheath diameter and whether those changes relate to other intraoperative parameters. Data will be collected at a single center and analyzed to compare the two surgical approaches.

Why it matters

Potential benefit: If successful, the findings could help guide anesthetic and positioning practices to reduce intracranial pressure–related risks during prostatectomy.

How similar studies have gone: Previous small studies have reported increases in optic nerve sheath diameter with steep Trendelenburg and pneumoperitoneum, but results are variable and larger comparative data are limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age ≥ 18 years
* ASA physical status I-III
* Patients scheduled for robot-assisted laparoscopic radical prostatectomy or open radical prostatectomy under general anesthesia
* Written informed consent obtained

Exclusion Criteria:

* History of intracranial surgery or intracranial lesion
* Known ocular disease (glaucoma, retinal detachment, diabetic retinopathy, previous ocular surgery, etc.)
* Intraocular pressure greater than 30 mmHg
* Refusal to participate in the study

Where it's running

  • Ege University Faculty of Medicine Hospital
    Izmir, İzmir, Turkey (Türkiye)
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.