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Clinical Trials/NCT07491198
NCT07491198
Recruiting
Not Applicable

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

Ege University1 site in 1 country50 target enrollmentStarted: January 5, 2026Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
50
Locations
1
Primary Endpoint
Optic Nerve Sheath Diameter

Overview

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.

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 pressure during surgery.

In this prospective study, patients undergoing robot-assisted laparoscopic radical prostatectomy will be compared with patients undergoing open radical prostatectomy. Optic nerve sheath diameter will be measured at predefined time points during surgery using ocular ultrasonography. Hemodynamic parameters, respiratory variables, intra-abdominal pressure, duration of surgery, blood loss, and administered fluids will also be recorded.

The aim of this study is to evaluate the effect of pneumoperitoneum and steep Trendelenburg position on optic nerve sheath diameter and to determine the relationship between optic nerve sheath diameter and intraoperative physiological changes.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Optic Nerve Sheath Diameter

Time Frame: During surgery at predefined intraoperative time points

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nursen Karaca

Anesthesiologist, MD

Ege University

Study Sites (1)

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