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| ID | Type | Description | Link |
|---|---|---|---|
| AbdurrahmanYAOTRH | Other Identifier | Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the start of anesthesia induction until the end of the surgical procedure (approximately 1 to 3 hours). |
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Inclusion Criteria:
Exclusion Criteria:
This study is conducted on patients scheduled for elective gynecological oncology surgery; therefore, only female participants are eligible for inclusion.
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital | Ankara | 06 | Turkey (Türkiye) |
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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| 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. |
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| 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. | 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. | During the first 60 minutes in the post-anesthesia care unit (PACU). |