Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Actively Recruiting
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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