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Clinical Trial NCT07491198 (ONSD-RALP) for Prostate Cancer, Optic Nerve Sheath Diameter, Robot-Assisted Radical Prostatectomy, Steep Trendelenburg Position With Penumoperitoneum in Robot Assisted Laparoscopic Prostatectomy is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Effect Of Trendelenburg Position And Pneumoperitoneum On Optic Nerve Sheath Diameter In Robot-Assisted Prostatectomy (ONSD-RALP) 50 Non-Invasive

Recruiting
Clinical Trial NCT07491198 (ONSD-RALP) is an observational study for Prostate Cancer, Optic Nerve Sheath Diameter, Robot-Assisted Radical Prostatectomy, Steep Trendelenburg Position With Penumoperitoneum in Robot Assisted Laparoscopic Prostatectomy that is recruiting. It started on 5 January 2026 with plans to enroll 50 participants. Led by Ege University, it is expected to complete by 1 September 2026. The latest data from ClinicalTrials.gov was last updated on 24 March 2026.
Brief Summary
This prospective study aims to evaluate the effect of steep Trendelenburg position and pneumoperitoneum on optic nerve sheath diameter in patients undergoing robot-assisted laparoscopic radical prostatectomy and open radical prostatectomy under general anesthesia. Increased intracranial pressure may occur during robotic surgery due to pneumoperitoneum and head-down positioning. Optic nerve sheath diameter measured by...Show More
Detailed Description
Robot-assisted laparoscopic radical prostatectomy requires steep Trendelenburg positioning and carbon dioxide pneumoperitoneum to improve the surgical field. These conditions may lead to increased intracranial pressure due to venous congestion and elevated intrathoracic pressure. Optic nerve sheath diameter measurement by ultrasonography is a noninvasive method that can be used to estimate changes in intracranial pre...Show More
Official Title

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

Conditions
Prostate CancerOptic Nerve Sheath DiameterRobot-Assisted Radical ProstatectomySteep Trendelenburg Position With Penumoperitoneum in Robot Assisted Laparoscopic Prostatectomy
Other Study IDs
  • ONSD-RALP
  • 25-12.1T/18
  • 25-12.1T/18 (Other Identifier) (Ege University Medical Research Ethics Committee)
NCT ID Number
NCT07491198
Start Date (Actual)
2026-01-05
Last Update Posted
2026-03-24
Completion Date (Estimated)
2026-09
Enrollment (Estimated)
50
Study Type
Observational
Status
Recruiting
Keywords
Optic Nerve Sheath Diameter
Trendelenburg Position
Pneumoperitoneum
Robot-Assisted Radical Prostatectomy
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Robot-Assisted Radical Prostatectomy
Patients undergoing robot-assisted laparoscopic radical prostatectomy under general anesthesia.
N/A
Open Radical Prostatectomy
Patients undergoing open radical prostatectomy under general anesthesia.
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Optic Nerve Sheath Diameter
Measurement of optic nerve sheath diameter using ocular ultrasonography during surgery.
During surgery at predefined intraoperative time points
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Male
  • 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

  • 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
Ege University logoEge University
Study Responsible Party
Nursen Karaca, Principal Investigator, Anesthesiologist, MD, Ege University
Study Central Contact
Contact: Nursen Karaca, MD, +902323902142, [email protected]
1 Study Locations in 1 Countries
Ege University Faculty of Medicine Hospital, Izmir, 35100, Turkey (Türkiye)
Nursen Karaca, MD, Contact, +902323902142, [email protected]
Işık Alper, Professor of Anesthesiology, Contact, +902323902140, [email protected]
Recruiting