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

NCT07491198 | Recruiting

• 1 other identifier: 25-12.1T/18
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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 ocular ultrasonography is a non-invasive method used to assess intracranial pressure changes. Hemodynamic and respiratory parameters will also be recorded during surgery. The results of this study may help to better understand the physiological effects of surgical position and pneumoperitoneum during prostatectomy procedures.

Conditions

Prostate Cancer; Optic Nerve Sheath Diameter; Robot-Assisted Radical Prostatectomy; Steep Trendelenburg Position With Penumoperitoneum in Robot Assisted Laparoscopic Prostatectomy

Keywords

Optic Nerve Sheath Diameter; Trendelenburg Position; Pneumoperitoneum; Robot-Assisted Radical Prostatectomy

Outcome Measures

Primary Outcomes (1)

• Optic Nerve Sheath Diameter

  Measurement of optic nerve sheath diameter using ocular ultrasonography during surgery.

  During surgery at predefined intraoperative time points

Study Arms (2)

Robot-Assisted Radical Prostatectomy

Patients undergoing robot-assisted laparoscopic radical prostatectomy under general anesthesia.

Open Radical Prostatectomy

Patients undergoing open radical prostatectomy under general anesthesia.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult male patients aged 18 years and older with ASA physical status I-III who are scheduled for robot-assisted laparoscopic radical prostatectomy or open radical prostatectomy under general anesthesia at Ege University Faculty of Medicine Hospital will be included in this prospective observational study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University Faculty of Medicine Hospital

Izmir, 35100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Pneumoperitoneum

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Peritoneal Diseases; Digestive System Diseases

Study Officials

• NURSEN KARACA, MD

  Ege University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nursen Karaca, MD

CONTACT

+902323902142; dr.nursenkaraca@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, MD

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: January 5, 2026
• Primary Completion: June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)