DSA vs. BIS for Anesthesia and Analgesia Management (NCT07502261) | Clinical Trial Compass
CompletedNot Applicable
DSA vs. BIS for Anesthesia and Analgesia Management
Turkey (Türkiye)45 participantsStarted 2025-04-01
Plain-language 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
Who can participate
Age range
18 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total Amount of Propofol Consumption
Timeframe: From the start of anesthesia induction until the end of the surgical procedure (approximately 1 to 3 hours).
Trial details
NCT IDNCT07502261
SponsorDr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital