Anesthesia, GeneralDSA-PRECISIONNCT07502261
DSA vs. BIS for Anesthesia and Analgesia Management
An observational study of Anesthesia, General and Gynecologic Surgical Procedures, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Anesthesia, General, Gynecologic Surgical Procedures, Intraoperative Monitoring
- What is being tested?
- Density Spectral Array (DSA) Monitoring and Bispectral Index (BIS) Monitoring
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 1 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Aged between 18 and 65 years
- ASA 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
Who cannot join
- Allergy or hypersensitivity to propofol, opioids, or lidocaine
- Liver failure or kidney failure
- Previous adjuvant chemotherapy
- Emergency surgery
- Operations lasting longer than 3 hours
- Neurological diseases such as epilepsy, Alzheimer's disease, or dementia
Show all 13Show fewer
- Cerebrovascular disease or known brain lesions
- Heart conduction disorders such as high-degree atrioventricular block
- Patients requiring premedication
- History of chronic pain
- Chronic opioid use
- Diabetes mellitus with neuropathy
- Patients unable to establish cooperation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, 06
About this study
Official title: Density Spectral Array Provides Intraoperative Precision Anesthesia and Analgesia Management; A Prospective Observational Study
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
Read the 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
- Being tested
- Density Spectral Array (DSA) Monitoring, Bispectral Index (BIS) Monitoring
- Keywords
- dsa, hypnosis, nociception, eeg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Density Spectral Array (DSA) MonitoringDevice
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.
Bispectral Index (BIS) MonitoringDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Bispectral Index (BIS) Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The total amount of remifentanil (in micrograms) administered to the patient during the entire surgical procedure to maintain the target analgesia level. The study compares whether monitoring with Density Spectral Array (DSA) leads to a significant reduction in total remifentanil consumption compared to Bispectral Index (BIS) monitoring.
Measured: 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)
Assessment of postoperative pain using the Visual Analog Scale (VAS), where 0 represents no pain and 10 represents the worst possible pain. The scores will be recorded to evaluate the quality of postoperative analgesia between the two groups.
Measured: At the 15th, 30th, and 60th minutes in the post-anesthesia care unit (PACU).
Postoperative Rescue Analgesic Requirement
The total amount and frequency of additional (rescue) analgesic medications required by the patient in the recovery unit. This measure evaluates whether the intraoperative anesthesia management with Density Spectral Array (DSA) reduces the need for extra pain relief compared to Bispectral Index (BIS) monitoring.
Measured: During the first 60 minutes in the post-anesthesia care unit (PACU).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 Apr 2025
- Primary completion31 Dec 2025
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, GeneralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Burak Çalışıcı, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502261
- Sponsor's protocol ID
- 2025-03/51
- Other IDs
- AbdurrahmanYAOTRH
- Acronym
- DSA-PRECISION
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared to ensure patient confidentiality and data privacy, as per the institutional ethics committee guidelines. The study results will be disseminated through peer-reviewed publications and conference presentations in an aggregated format, ensuring that no individual patient can be identified.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Density Spectral Array Provides Intraoperative Precision Anesthesia and Analgesia Management; A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07502261
- Acronym / sponsor ID
- DSA-PRECISION / 2025-03/51
- Conditions
- Anesthesia, General, Gynecologic Surgical Procedures, Intraoperative Monitoring, Anesthesia Depth Monitoring
- Keywords
- dsa, hypnosis, nociception, eeg
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DSA Group (Density Spectral Array) | – | Device: Density Spectral Array (DSA) MonitoringPatients 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. |
| BIS Group (Bispectral Index) | – | Device: Bispectral Index (BIS) MonitoringPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Aged between 18 and 65 years
- ASA physical status I-III
- Patients scheduled for elective gynecological oncology surgery
- Body mass index (BMI) ≤ 35 kg/m²
- Able to provide voluntary informed consent
Key exclusion criteria (13 listed)
- Allergy or hypersensitivity to propofol, opioids, or lidocaine
- Liver failure or kidney failure
- Previous adjuvant chemotherapy
- Emergency surgery
- Operations lasting longer than 3 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Density Spectral Array (DSA) MonitoringAnesthesia 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 | DSA Group (Density Spectral Array) |
| Bispectral Index (BIS) MonitoringAnesthesia 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. | Device | BIS Group (Bispectral Index) |
Primary outcome
Total Amount of Propofol Consumption
Time frame: From the start of anesthesia induction until the end of the surgical procedure (approximately 1 to 3 hours).
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.
3 secondary outcomes
Total Amount of Remifentanil Consumption
Time frame: 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)
Time frame: At the 15th, 30th, and 60th minutes in the post-anesthesia care unit (PACU).
Postoperative Rescue Analgesic Requirement
Time frame: During the first 60 minutes in the post-anesthesia care unit (PACU).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared to ensure patient confidentiality and data privacy, as per the institutional ethics committee guidelines. The study results will be disseminated through peer-reviewed publications and conference presentations in an aggregated format, ensuring that no individual patient can be identified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, General and Gynecologic Surgical Procedures, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Amount of Propofol Consumption (time frame: From the start of anesthesia induction until the end of the surgical procedure (approximately 1 to 3 hours).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.