Effect of Head-down Position on a Brain Monitoring Index During Hysterectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational study will monitor adult women undergoing elective laparoscopic hysterectomy under general anesthesia. Researchers will record the Patient State Index (PSI) and frontal cerebral oxygen saturation (rSO₂) using non-invasive sensors, alongside standard intraoperative data, to see if the Trendelenburg position alters EEG-based depth-of-anesthesia readings and cerebral oxygenation. No additional interventions will be performed beyond routine care. The study will explore associations between changes in PSI and changes in cerebral hemodynamics and other physiological parameters. Results may help interpret EEG-derived depth-of-anesthesia metrics in positions that affect cerebral physiology.

Why it matters

Who can join: the full rules

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)

Where it's running

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

Study contacts

• Principal investigator: Ayca Tas Tuna, Professor, M.D. — Sakarya University Faculty of Medicine
• Study coordinator: Ayca Tas Tuna, Professor, M.D.
• Email: aycatas@yahoo.com
• Phone: +90 532 300 48 26

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.