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Effect of Trendelenburg Position on Patient State Index

Recruitingn/aAges 18 Years - 65 YearsFemaleSakarya University
NCT07467200 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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)
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What it tests

  • Not listed
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Where

1 site
Sakarya University Training and Research Hospital, Department of Anesthesiology and Reanimation
Sakarya, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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