NCT07502261

DSA vs. BIS for Anesthesia and Analgesia Management

Density Spectral Array Provides Intraoperative Precision Anesthesia and Analgesia Management; A Prospective Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 45 (actual)
• Sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare two different methods of monitoring brain activity (anesthesia depth) during gynecological surgeries. When patients undergo surgery under general anesthesia, doctors use monitors to ensure they are at the right level of sleep and pain relief. Traditionally, a method called the Bispectral Index (BIS) is used, which provides a single number to represent brain activity. A newer method, called Density Spectral Array (DSA), provides a more detailed, color-coded map of brain waves in real-time. Researchers want to see if using the more detailed DSA map helps anesthesiologists adjust medication more precisely. The study will compare the total amount of anesthetic and pain-relief drugs used in patients monitored with DSA versus those monitored with BIS. The goal is to determine if DSA leads to more personalized care, potentially reducing drug use and improving recovery after surgery

Detailed description

This prospective observational study will include 45 patients undergoing elective gynecological oncology surgery under general anesthesia. Patients will be monitored using standard anesthesia monitoring (Pulse oximetry, non-invasive blood pressure, ECG, and ETCO2) along with brain activity monitoring. The anesthesia management will follow a Total Intravenous Anesthesia (TIVA) protocol consisting of propofol, remifentanil, and lidocaine. Patients will be divided into two groups based on the anesthesiologist's preference for monitoring anesthesia depth: the Bispectral Index (BIS) group and the Density Spectral Array (DSA) group. Hemodynamic parameters (heart rate, blood pressure), BIS values, and DSA images will be recorded at specific intervals: before induction, after induction, at the start of surgery, every 30 minutes during the procedure, at the end of surgery, and after extubation. The total amounts of propofol and remifentanil used during the operation will be documented for each patient. In the postoperative period, patients will be monitored in the recovery unit at the 15th, 30th, and 60th minutes. Visual Analog Scale (VAS) scores for pain, additional analgesic requirements, and hemodynamic parameters will be recorded. Once orientation and cooperation are established, patients will also be evaluated for any signs of intraoperative awareness

Conditions

• Anesthesia, General
• Gynecologic Surgical Procedures
• Intraoperative Monitoring
• Anesthesia Depth Monitoring

Interventions

Type	Name	Description
DEVICE	Density Spectral Array (DSA) Monitoring	Anesthesia depth and analgesia will be managed using real-time color-coded EEG power spectrum analysis (Density Spectral Array). The anesthesiologist will adjust the infusion rates of propofol and remifentanil based on the visual representation of brain wave frequencies and power distribution. This method allows for a more detailed and individualized assessment of the patient's response to anesthetic and analgesic agents compared to numerical indices alone.
DEVICE	Bispectral Index (BIS) Monitoring	Anesthesia depth will be managed using the processed EEG numerical index (Bispectral Index). The anesthesiologist will adjust the infusion rates of propofol and remifentanil to maintain a target BIS value between 40 and 60. This represents the standard clinical practice for monitoring the hypnotic component of general anesthesia using a simplified numerical scale from 0 to 100.

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-12-31
• Completion: 2026-03-01
• First posted: 2026-03-30
• Last updated: 2026-04-06

Locations

1 site across 1 country: Turkey (Türkiye)