DSA vs. BIS for Anesthesia and Analgesia Management

NCT07502261 | Completed

• 2 other identifiers: 2025-03/51AbdurrahmanYAOTRH
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Keywords

dsa; hypnosis; nociception; eeg

Outcome Measures

Primary Outcomes (1)

• Total Amount of Propofol Consumption

  The total amount of propofol (in milligrams) administered to the patient during the entire surgical procedure to maintain the target anesthesia depth. The study compares whether monitoring with Density Spectral Array (DSA) leads to a significant reduction in total propofol consumption compared to Bispectral Index (BIS) monitoring.

  From the start of anesthesia induction until the end of the surgical procedure (approximately 1 to 3 hours).

Secondary Outcomes (3)

• Total Amount of Remifentanil Consumption

  From the start of anesthesia induction until the end of the surgical procedure (approximately 1 to 3 hours).

• Postoperative Pain Scores (Visual Analog Scale - VAS)

  At the 15th, 30th, and 60th minutes in the post-anesthesia care unit (PACU).

• Postoperative Rescue Analgesic Requirement

  During the first 60 minutes in the post-anesthesia care unit (PACU).

Study Arms (2)

DSA Group (Density Spectral Array)

Patients in this group will have their anesthesia depth monitored and managed using Density Spectral Array (DSA) in addition to standard monitoring. Anesthesia will be maintained using a Total Intravenous Anesthesia (TIVA) protocol with propofol, remifentanil, and lidocaine. The anesthesiologist will adjust the drug infusion rates based on real-time color-coded brain wave maps provided by the DSA to maintain an optimal level of anesthesia and analgesia.

Device: Density Spectral Array (DSA) Monitoring

BIS Group (Bispectral Index)

Patients in this group will have their anesthesia depth monitored and managed using the Bispectral Index (BIS) in addition to standard monitoring. Anesthesia will be maintained using a Total Intravenous Anesthesia (TIVA) protocol with propofol, remifentanil, and lidocaine. The anesthesiologist will adjust the drug infusion rates based on the numerical BIS values (target range 40-60) to maintain an optimal level of anesthesia and analgesia.

Device: Bispectral Index (BIS) Monitoring

Interventions

Density Spectral Array (DSA) Monitoring DEVICE

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.

DSA Group (Density Spectral Array)

Bispectral Index (BIS) Monitoring DEVICE

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.

BIS Group (Bispectral Index)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: This study is conducted on patients scheduled for elective gynecological oncology surgery; therefore, only female participants are eligible for inclusion.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of female patients aged 18-65 years, with an ASA physical status of I-III, who are scheduled for elective gynecological oncology surgery under general anesthesia at a single tertiary oncology center. Participants are selected from patients who meet the inclusion criteria and do not require premedication, ensuring a standardized group for monitoring anesthesia depth and drug consumption.

You may qualify if:

• Aged between 18 and 65 years. ASA (American Society of Anesthesiologists) physical status I-III. Patients scheduled for elective gynecological oncology surgery. Body Mass Index (BMI) ≤ 35 kg/m². Able to provide voluntary informed consent. Patients who do not require premedication.

You may not qualify if:

• Allergy or hypersensitivity to the drugs used (propofol, opioids, lidocaine). Patients with liver or kidney failure. Patients who have previously received adjuvant chemotherapy. Emergency surgery. Operations lasting longer than 3 hours. Neurological diseases such as Epilepsy, Alzheimer's, or Dementia. Cerebrovascular disease and known brain lesions. Heart conduction disorders (e.g., high-degree AV block). Patients requiring premedication. History of chronic pain or chronic opioid use. Diabetes Mellitus with developed neuropathy. Patients with whom cooperation cannot be established.

Sponsors & Collaborators

• Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital: lead

Study Sites (1)

Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, 06, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Muhammed Burak Çalışıcı

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: March 30, 2026
• Study Start: April 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: March 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)