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Clinical Trials/NCT07632287
NCT07632287CompletedNot Applicable

Comparison of the Effects of Standard Trendelenburg and Modified Z Trendelenburg Positions on Cerebral Oxygenation (NIRS) and Optic Nerve Sheath Diameter in Laparoscopic Gynecological Cases

Ankara Etlik City Hospital1 site in 1 country70 target enrollmentStarted: March 6, 2026Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
70
Locations
1

Study Overview

Brief Summary

The purpose of this study is to compare the effects of the standard Trendelenburg position and the modified Z-Trendelenburg position on cerebral oxygenation and optic nerve sheath diameter (ONSD) in patients undergoing laparoscopic surgery. The prolonged use of the standard Trendelenburg position combined with pneumoperitoneum can increase intracranial pressure and affect cerebral blood flow. In this study, researchers will use non-invasive methods, including Near-Infrared Spectroscopy (NIRS) to monitor regional cerebral oxygenation, and ocular ultrasonography to measure ONSD as an indicator of intracranial pressure changes. The main goal is to determine whether the modified Z-Trendelenburg position serves as a safer physiological alternative by reducing these potential adverse effects compared to the standard position.

Detailed Description

Laparoscopic surgeries frequently require patients to be placed in a steep Trendelenburg position with pneumoperitoneum to provide optimal surgical exposure. However, this combination induces significant physiological alterations, most notably an increase in intracranial pressure (ICP) and a potential compromise in cerebral venous drainage and regional cerebral oxygen saturation (rSO2). Non-invasive monitoring techniques, such as measuring the optic nerve sheath diameter (ONSD) via ultrasonography, provide reliable, real-time estimates of ICP changes. Additionally, Near-Infrared Spectroscopy (NIRS) allows for the continuous monitoring of cerebral oxygenation.

This prospective clinical study is designed to evaluate and compare the cerebral and hemodynamic impacts of the standard straight Trendelenburg position versus a modified Z-Trendelenburg position. Participants scheduled for elective laparoscopic procedures will be divided into specific positioning groups. Hemodynamic parameters, NIRS values, and ONSD measurements will be recorded at predefined time points throughout the surgery: at baseline, post-induction, after the establishment of pneumoperitoneum and positioning, at specific intervals during the surgery, and post-operatively in the recovery room. The primary hypothesis is that the modified Z-Trendelenburg position will attenuate the rise in ICP (reflected by a smaller increase in ONSD) and provide better cerebral oxygenation stability compared to the traditional standard position.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Patients aged between 18 and 70 years
  • American Society of Anesthesiologists (ASA) physical status I or II
  • Scheduled for elective laparoscopic surgery requiring Trendelenburg position
  • Provided written informed consent

Exclusion Criteria

  • Patient refusal to participate
  • History of severe cerebrovascular disease
  • Known increased intracranial pressure
  • Pre-existing ocular pathology that could affect optic nerve sheath diameter (ONSD) measurements (e.g., glaucoma, optic neuritis, ocular trauma)
  • Severe cardiovascular or pulmonary disease Body Mass Index (BMI) greater than 35 kg/m^2 Pregnancy

Investigators

Sponsor
Ankara Etlik City Hospital
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Neriman Doğan

Resident Physician, Department of Anesthesiology and Reanimation

Ankara Etlik City Hospital

Study Sites (1)

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