Clinical Trial

Effect of Trendelenburg Position on Patient State Index

Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated June 4, 2026 (before its estimated August 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this observational study is to evaluate whether the Trendelenburg position affects electroencephalography-based depth of anesthesia monitoring and cerebral oxygenation during general anesthesia. The main questions it aims to answer are: * Does the Trendelenburg position cause a change in the Patient State Index (PSI), an Electroensephalography (EEG)-derived indicator of anesthetic depth? * Are changes in PSI associated with changes in frontal cerebral oxygen saturation (rSO₂) and hemodynamic parameters? The study will include adult female patients undergoing elective laparoscopic gynecologic surgery under general anesthesia. Participants will receive standard anesthesia and routine intraoperative monitoring. In addition to standard monitoring, Patient State Index (PSI) and frontal cerebral oxygen saturation (rSO₂) will be recorded using non-invasive sensors. No additional intervention will be performed for research purposes. Physiological parameters including PSI, cerebral oxygen saturation, mean arterial pressure, heart rate, oxygen saturation, and end-tidal carbon dioxide will be recorded at predefined intraoperative time points before and after the Trendelenburg position. The study aims to determine whether position-related physiological changes influence EEG-based anesthesia depth indices and to improve the interpretation of intraoperative brain monitoring.
Protocol Amendment History 2 changes
critical Recruitment opened 2026-06-05
notable Primary completion pushed: 2026-07-01 -> 2026-08-01 2026-06-05
Trial Details
NCT Number NCT07467200
Lead Sponsor Sakarya University
Conditions Laparoscopic Hysterectomy
Enrollment 60 participants
Start Date 2026-05-01
Primary Completion 2026-08-01 (estimated)
Study Completion 2026-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-04