Effect of Trendelenburg Position on Patient State Index

Recruiting now

Conditions studied: Laparoscopic Hysterectomy

In brief

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.

Key facts

Study ID

NCT07467200

Run by

Sakarya University

People needed

60

Starts

2026-05-01

Expected to finish

2026-12-01

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female patients aged 18-65 years
• American Society of Anesthesiologists (ASA) physical status I-III
• Scheduled for elective laparoscopic hysterectomy under general anesthesia
• Ability to provide written informed consent

You may not qualify if…

• History of neurological disease (e.g., stroke, epilepsy)
• Known cerebrovascular disease, glaucoma, or retinal disease
• Severe cardiac or pulmonary disease
• Contraindication to near-infrared spectroscopy sensor placement
• Obesity (Body Mass Index > 35 kg/m²)

Where it is running

• Sakarya University Training and Research Hospital, Department of Anesthesiology and Reanimation — Sakarya, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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