Ireland
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Recruiting Observational

Effect of Trendelenburg Position on Patient State Index

NCT07467200 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2026-05-01
Last updated
2026-06-04

Condition(s) studied

Laparoscopic Hysterectomy

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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)

Primary outcome measure(s)

  • Change in Patient State Index (ΔPSI) After Trendelenburg Position — From Post-intubation (Supine) to Trendelenburg Positioning
    The primary outcome is the change in Patient State Index (PSI), an Electroensephalography(EEG)-derived indicator of anesthetic depth, between the supine position after tracheal intubation and the early Trendelenburg position following pneumoperitoneum. PSI values will be recorded using the Masimo SedLine monitoring system. The analysis will evaluate whether Trendelenburg positioning is associated with a significant change in PSI independent of anesthetic drug concentration.

Trial sites (1)

FacilityCityRegionStatus
Sakarya University Training and Research Hospital, Department of Anesthesiology and Reanimation Sakarya Turkey (Türkiye) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07467200 on ClinicalTrials.gov ↗ ← All trials in Turkey