Actively Recruiting

Age: 18Years - 65Years
FEMALE
ID07467200

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

Led by Sakarya University · Updated on 2026-06-04

60

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to understand how the Trendelenburg position, often used during laparoscopic pelvic surgery, affects brain monitoring during general anesthesia in adult female patients undergoing elective laparoscopic hysterectomy. Specifically, it evaluates whether this position changes the Patient State Index (PSI), which measures anesthetic depth from EEG signals, and whether these changes relate to cerebral oxygen levels and other vital signs. The study is observational and does not introduce any new treatments or interventions. Participants will receive standard anesthesia care and routine monitoring including heart rate, blood pressure, oxygen saturation, and end-tidal carbon dioxide. In addition to these, non-invasive sensors will record the PSI and frontal cerebral oxygen saturation (rSO2) throughout the surgery. Measurements will be taken at key times such as before anesthesia, after intubation, after creating pneumoperitoneum, and during the Trendelenburg position. No extra procedures will be performed beyond routine clinical practice. During the surgery, researchers will collect data on PSI, cerebral oxygen saturation, mean arterial pressure, heart rate, and other physiological parameters at specific time points to observe any changes caused by patient positioning. This information will help clarify how body position influences brain monitoring and anesthetic depth readings. The study will run until December 2026, and participation involves only the observational recording of routine clinical and anesthesia monitoring data.

CONDITIONS

Brief Title

Effect of Trendelenburg Position on Patient State Index

Who Can Participate

Age: 18Years - 65Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Duration of surgery and anesthesia (several hours)

Participants undergo elective laparoscopic hysterectomy under general anesthesia with routine intraoperative monitoring. Additional physiological parameters including depth of anesthesia (Patient State Index) and frontal cerebral oxygen saturation are recorded at predefined intraoperative time points before and after pneumoperitoneum and Trendelenburg positioning.

1 surgical procedure with continuous monitoring

Trial Site Locations

Total: 1 location

1

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

Sakarya, Turkey (Türkiye)

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Research Team

A

Ayca Tas Tuna, Professor, M.D.

A

Ahmet R Dogan, M.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Patient state index and cerebral blood flow changes during shoulder arthroscopy in beach chair position.

Mehmet Ilke Buget, Ata Can Atalar, Ipek Saadet Edipoglu...

https://pubmed.ncbi.nlm.nih.gov/27591460