Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07467200

Effect of Trendelenburg Position on Patient State Index

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

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

Sakarya, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ahmet Ridvan Dogan

CONTACT

[email protected]

About this study

Electroencephalography (EEG)-based depth of anesthesia monitors are widely used to assess the hypnotic component of general anesthesia. The Patient State Index (PSI) is a processed EEG parameter derived from frontal EEG signals and provides a numerical estimate of anesthetic depth ranging from 0 to 100. Although these indices are primarily designed to reflect the pharmacologic effects of anesthetic agents, physiological factors that influence cerebral hemodynamics may also affect EEG-derived parameters.

The Trendelenburg position is frequently used during laparoscopic pelvic surgery to improve surgical exposure. This position can alter venous return, increase cerebral venous pressure, and influence intracranial dynamics. When combined with pneumoperitoneum, these physiological changes may modify cerebral blood flow and cerebral oxygenation. Such alterations may potentially influence EEG-based indices of anesthetic depth independently of anesthetic drug concentration.

Previous studies have demonstrated that body position can influence processed EEG indices such as the bispectral index (BIS), particularly in the beach-chair position. However, the response of the Patient State Index to the Trendelenburg position has not been clearly established.

This prospective observational study aims to evaluate whether the Trendelenburg position affects PSI values during general anesthesia and to investigate the relationship between PSI changes and cerebral oxygenation measured by near-infrared spectroscopy (NIRS).

Adult female patients undergoing elective laparoscopic hysterectomy under general anesthesia will be included. Standard intraoperative monitoring will be applied, including electrocardiography, non-invasive blood pressure, pulse oximetry, end-tidal carbon dioxide, and anesthetic gas monitoring. In addition, EEG-based depth of anesthesia monitoring will be performed using the PSI monitor (Masimo SedLine), and frontal cerebral oxygen saturation (rSO₂) will be 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 will be recorded at predefined intraoperative time points: before induction of anesthesia, after tracheal intubation in the supine position, after pneumoperitoneum, and at several intervals following the Trendelenburg position.

No intervention will be performed for research purposes. Anesthetic management and surgical positioning will follow routine clinical practice. The study will analyze whether position-related physiological changes are associated with variations in PSI and whether these changes correlate with cerebral oxygenation or hemodynamic parameters.

Understanding the influence of patient positioning on EEG-based anesthesia depth indices may improve the interpretation of intraoperative brain monitoring and help prevent unnecessary adjustments of anesthetic drug dosing.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Change in Patient State Index (ΔPSI) After Trendelenburg Position

    Time frame: From Post-intubation (Supine) to Trendelenburg Positioning

    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.

Secondary outcomes

  1. Change in Frontal Cerebral Oxygen Saturation (rSO₂)

    Time frame: Intraoperative period (recorded at predefined time points before and after Trendelenburg positioning)

    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).

  2. Mean Arterial Pressure Changes During Trendelenburg Position

    Time frame: Intraoperative period (recorded at predefined time points before and after Trendelenburg positioning)

    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.

  3. Heart Rate Changes During Trendelenburg Position

    Time frame: Intraoperative period (recorded at predefined time points before and after Trendelenburg positioning)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmet R Dogan, M.D.

CONTACT

+905427988070

Ayca Tas Tuna, Professor, M.D.

CONTACT

[email protected]

+90 532 300 48 26

Sponsors and collaborators

Lead sponsor

Sakarya University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.