Effect of Trendelenburg Position on Patient State Index
ConditionLaparoscopic Hysterectomy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-65
SponsorSakarya University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
The study population consists of adult female patients undergoing elective laparoscopic hysterectomy under general anesthesia at a tertiary care university-affiliated hospital. Eligible patients will be recruited consecutively among those scheduled for surgery who meet the inclusion criteria and provide written informed consent.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 1 trial groupGroup A: Patients Undergoing Laparoscopic Hysterectomy in Trendelenburg Position
Trial outcomes
Primary outcomes
1
Change in Patient State Index (ΔPSI) After Trendelenburg Position
The primary outcome is the change in Patient State Index (PSI), an Electroensephalography(EEG)-derived indicator of anesthetic depth, between the supine position after tracheal intubation and the early Trendelenburg position following pneumoperitoneum. PSI values will be recorded using the Masimo SedLine monitoring system. The analysis will evaluate whether Trendelenburg positioning is associated with a significant change in PSI independent of anesthetic drug concentration.
Time frame
From Post-intubation (Supine) to Trendelenburg PositioningSecondary outcomes
1
Change in Frontal Cerebral Oxygen Saturation (rSO₂)
Frontal cerebral oxygen saturation (rSO₂) measured using near-infrared spectroscopy sensors will be recorded to evaluate changes in cerebral oxygenation associated with pneumoperitoneum and Trendelenburg positioning. The analysis will assess whether changes in rSO₂ occur during Trendelenburg positioning and whether these changes are associated with variations in Patient State Index (PSI).
Time frame
Intraoperative period (recorded at predefined time points before and after Trendelenburg positioning)2
Mean Arterial Pressure Changes During Trendelenburg Position
Mean arterial pressure (MAP) will be recorded to evaluate hemodynamic changes associated with pneumoperitoneum and Trendelenburg positioning and to explore its relationship with changes in Patient State Index and cerebral oxygen saturation.
Time frame
Intraoperative period (recorded at predefined time points before and after Trendelenburg positioning)3
Heart Rate Changes During Trendelenburg Position
Heart rate will be monitored to evaluate intraoperative hemodynamic responses associated with pneumoperitoneum and Trendelenburg positioning and to assess its relationship with changes in Patient State Index and cerebral oxygen saturation.
Time frame
Intraoperative period (recorded at predefined time points before and after Trendelenburg positioning)Sponsors and contacts
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Source ClinicalTrials.gov