RecruitingNCT07467200

Effect of Trendelenburg Position on Patient State Index

Effect of the Trendelenburg Position on Patient State Index and Frontal Cerebral Oxygenation: A Prospective Observational Study


Sponsor

Sakarya University

Enrollment

60 participants

Start Date

May 1, 2026

Study Type

OBSERVATIONAL

Conditions

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: FEMALEMin Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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)

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Locations(1)

Sakarya University Training and Research Hospital, Department of Anesthesiology and Reanimation

Sakarya, Turkey (Türkiye)

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NCT07467200


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