Actively Recruiting

Age: 18Years +
MALE
ID07491198

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

Led by Ege University · Updated on 2026-03-24

50

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate how the steep Trendelenburg position and pneumoperitoneum affect the optic nerve sheath diameter in patients undergoing robot-assisted laparoscopic radical prostatectomy compared to open radical prostatectomy. The study focuses on patients with prostate cancer and investigates how these surgical conditions might increase intracranial pressure during general anesthesia. Optic nerve sheath diameter is measured noninvasively using ocular ultrasonography to assess these pressure changes. Participants are divided into two groups: those having robot-assisted laparoscopic prostatectomy and those having open radical prostatectomy, both under general anesthesia. During surgery, optic nerve sheath diameter will be measured at set times, and other factors such as hemodynamic and respiratory parameters, intra-abdominal pressure, surgery duration, blood loss, and fluids given will be recorded to understand physiological changes. Patients will be carefully monitored throughout the surgery with ultrasound and other measures to track changes in intracranial pressure and related parameters. The main outcome measured is the optic nerve sheath diameter at specific intraoperative time points. This observational study is led by Ege University and will run until September 2026, with participants involved during their surgical procedure and data collection at those times.

CONDITIONS

Brief Title

Effect Of Trendelenburg Position And Pneumoperitoneum On Optic Nerve Sheath Diameter In Robot-Assisted Prostatectomy

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • ASA physical status I to III
  • Scheduled for robot-assisted laparoscopic radical prostatectomy or open radical prostatectomy under general anesthesia
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • History of intracranial surgery or intracranial lesion
  • Known ocular diseases such as glaucoma, retinal detachment, diabetic retinopathy, or previous ocular surgery
  • Intraocular pressure greater than 30 mmHg
  • Refusal to participate in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Duration of surgery

Participants undergo either robot-assisted laparoscopic radical prostatectomy or open radical prostatectomy under general anesthesia. Optic nerve sheath diameter and physiological parameters are measured during surgery using ocular ultrasonography.

Measurements taken at predefined intraoperative time points

Trial Site Locations

Total: 1 location

1

Ege University Faculty of Medicine Hospital

Izmir, Turkey (Türkiye), 35100

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Research Team

N

Nursen Karaca, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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