Hysterectomy Clinical Trials

Clinical trials related to Hysterectomy Procedure

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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Sakarya University Training and Research Hospital, Department of Anesthesiology and Reanimation
RECRUITING
Sakarya
Contact Information
Primary
Ayca Tas Tuna, Professor, M.D.
aycatas@yahoo.com
+90 532 300 48 26
Backup
Ahmet R Dogan, M.D.
+905427988070
Time Frame
Start Date: 2026-05-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 60
Treatments
Patients Undergoing Laparoscopic Hysterectomy in Trendelenburg Position
This cohort includes adult female patients undergoing elective laparoscopic hysterectomy under general anesthesia. All participants receive standard intraoperative monitoring as part of routine clinical care. In addition to routine monitoring, depth of anesthesia is assessed using the Patient State Index (PSI), and frontal cerebral oxygen saturation (rSO₂) is measured using near-infrared spectroscopy sensors.~Physiological parameters including PSI, cerebral oxygen saturation, mean arterial pressure, heart rate, oxygen saturation, and end-tidal carbon dioxide are recorded at predefined intraoperative time points before and after pneumoperitoneum and Trendelenburg positioning.~No intervention is performed for research purposes. Surgical positioning and anesthetic management follow routine clinical practice, and the study involves only the observational recording of physiological parameters.
Related Therapeutic Areas
Sponsors
Leads: Sakarya University

This content was sourced from clinicaltrials.gov