Head-down position and abdominal gas effects on optic nerve sheath size during robotic prostate removal
Effect of Steep Trendelenburg Position and Pneumoperitoneum on Optic Nerve Sheath Diameter in Robot-Assisted Laparoscopic Radical Prostatectomy: A Prospective Study
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 type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Ege University Academic / other |
| Locations | 1 site (Izmir) |
| Trial ID | NCT07491198 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Izmir
- Ege University Faculty of Medicine Hospital — Izmir, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Nursen Karaca, Md — Ege University
- Study coordinator: Nursen Karaca, MD
- Email: dr.nursenkaraca@hotmail.com
- Phone: +902323902142
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.