Geriatric Patient Care ImprovementNCT06844279
The Effects of Anesthesia Depth Monitoring on Postoperative Recovery and Cognitive Functions in the Geriatric Patient Population
A study testing Processed Electroencephalogram (BIS Index) and Processed Electroencephalogram (DSA Mode) in people with Geriatric Patient Care Improvement and Postoperative Delirium (POD), run by Aslıhan Güleç at 1 site in Turkey (Türkiye).
Trial summary
This study will be conducted on patients aged 65 and older scheduled for surgery due to lumbar or cervical disc herniation. General anesthesia is routinely used for these types of surgeries in the hospital. In patients receiving general anesthesia, anesthesia depth monitoring is performed. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Geriatric Patient Care Improvement, Postoperative Delirium (POD), Burst Suppression
- What is being tested?
- Processed Electroencephalogram (BIS Index) and Processed Electroencephalogram (DSA Mode)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2025to Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years and older
- Elective spinal surgeries
- ASA status I-III
Who cannot join
- Emergent surgeries
- ASA status IV-V
- Prediagnosed delirium and or dementia
- Inability to give consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University School of Medicine
Ankara, 06560
Aslihan Gulec Kilic, MD, +905072709000, aslihangulec@gazi.edu.tr
Gozde Inan, Associate Professor, +905358105620, inangozde@yahoo.com
About this study
Official title: Geriatrik Hasta Grubunda Anestezi Derinliği Monitörizasyonlarının Postoperatif Derlenme ve Bilişsel Fonksiyonlara Etkileri
This study will be conducted on patients aged 65 and older scheduled for surgery due to lumbar or cervical disc herniation. General anesthesia is routinely used for these types of surgeries in the hospital. In patients receiving general anesthesia, anesthesia depth monitoring is performed.
As part of the study, a preoperative anesthesia evaluation will be conducted, which will include age, weight, height, comorbidities, regularly used medications, previous surgical or anesthesia experiences, nutritional habits, mental status, and daily activity levels.
Read more
On the day of surgery, upon arrival in the operating room, the following will be measured and recorded:
- Blood pressure using a non-invasive blood pressure monitor
- Heart rate and rhythm via electrocardiogram (ECG)
- Blood oxygen level with a pulse oximeter
- Anesthesia depth using a forehead-applied sensor
All monitoring procedures are non-invasive and painless. Following the placement of these monitoring devices and initial measurements, anesthesia induction and surgery will commence. Throughout surgery, blood pressure, heart rate, and brain activity will be continuously recorded. After the surgical procedure, anesthesia emergence and mental status will be assessed. Preoperative evaluation data and intraoperative recordings will be used solely for research purposes, with patient identity information remaining confidential.
Read the detailed description
Perioperative cognitive decline and delirium occur more frequently in the geriatric population undergoing surgery. International guidelines recommend monitoring anesthesia depth to reduce the risk of postoperative cognitive dysfunction. Anesthesia depth is commonly measured using non-invasive electroencephalography (EEG)-based methods, such as the Bispectral Index (BIS).
Previous studies have predominantly utilized processed EEG monitors that generate numerical values for tracking anesthesia depth. However, in this study, anesthesia depth will be monitored using both the standard numerical BIS index and the Density Spectral Array (DSA) mode, an advanced feature of the BIS device. To date, no studies have simultaneously examined BIS and DSA modes in relation to cognitive function and the recovery process.
The use of advanced monitoring techniques may serve as a valuable resource for future research, particularly in optimizing anesthetic management for geriatric patients with reduced cognitive reserve. This study aims to evaluate the effects of different intraoperative anesthesia depth monitoring approaches, including hemodynamic monitoring, numerical BIS values, and DSA functions. The primary objective is to determine the optimal anesthesia monitoring strategy that minimizes intraoperative hypotension, burst suppression, and postoperative delirium.
- Being tested
- Control Group: Standard Hemodynamic Monitoring, Processed Electroencephalogram (BIS Index), Processed Electroencephalogram (DSA Mode)
- Keywords
- anaesthesia depth monitoring, geriatric, density spectral array, bispectral index, burst supression, postoperative delirium
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Group: Standard Hemodynamic MonitoringOther
Anesthesia depth monitoring based on hemodynamic values without additional processed EEG guidance.
Processed Electroencephalogram (BIS Index)Device
Anaesthesia depth monitoring according to numeric BIS index values.
Processed Electroencephalogram (DSA Mode)Device
Anaesthesia depth monitoring according to density spectral array functions
| Study group | Role | What they receive |
|---|---|---|
| Hemodynamic-Guided Group | Active comparator | Anesthesia depth monitoring will be managed according to hemodynamic parameters, primarily avoiding hypotension. Receives: Other: Control Group: Standard Hemodynamic Monitoring |
| BIS-Guided Group | Active comparator | Anaesthesia depth monitoring according to numeric BIS index values Receives: Device: Processed Electroencephalogram (BIS Index) |
| DSA-Guided Group | Active comparator | Anesthesia depth monitoring using the Density Spectral Array (DSA) function of the BIS monitor. Receives: Device: Processed Electroencephalogram (DSA Mode) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of Burst Suppression
The burst suppression ratio (BSR) will be calculated as the percentage of total anesthesia time spent in burst suppression, as measured by processed electroencephalography (EEG). A higher BSR has been associated with worse postoperative cognitive outcomes.
Measured: Intraoperative (continuously recorded from anesthesia induction to emergence)
Time of Burst Suppression
Anesthesia time spent in burst suppression (BS), as measured by processed electroencephalography (EEG). A higher BS time has been associated with worse postoperative cognitive outcomes.
Measured: Intraoperative (continuously recorded from anesthesia induction to emergence)
Intraoperative Hypotension Incidence
Intraoperative hypotension will be measured in 5-minute intervals. Hypotension is a mean arterial pressure (MAP) below 60 mmHg. The episodes of hypotension at any point during surgery will be recorded.
Measured: Intraoperative (assessed continuously throughout surgery)
Alpha Band Preservation or Loss
Alpha band activity (8-12 Hz) in the frontal lobe will be evaluated to determine whether it is preserved or lost during general anesthesia. Alpha band preservation is associated with optimal anesthesia depth and cognitive function preservation, while loss of alpha band activity is linked to increased postoperative cognitive impairment.
Measured: Intraoperative (measured continuously from anesthesia induction to emergence)
Secondary outcomes (5)
Incidence of Postoperative Delirium Assessed via CAM Scale
Postoperative delirium will be assessed using the Confusion Assessment Method (CAM) tool. The number of participants meeting the criteria for delirium within the first 48 hours postoperatively will be recorded.
Measured: Postoperative (assessed at 6, 24, and 48 hours after surgery)
Total Intraoperative Propofol Consumption
The total dose of propofol administered intraoperatively will be recorded. Data will be reported as mg/kg.
Measured: Intraoperative
Total Intraoperative Sevoflurane Consumption
The total dose of Sevoflurane administered intraoperatively will be recorded. Data will be reported as ml.
Measured: Intraoperative
Total Intraoperative Remifentanil Consumption
The total dose of Remifentanil administered intraoperatively will be recorded. Data will be reported as mcg/kg.
Measured: Intraoperative
Total Intraoperative Vasopressor Consumption
The total dose of vasopressors (noradrenaline, adrenaline, dopamine) administered intraoperatively will be recorded. Data will be reported as mcg/kg.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start10 Jan 2025
- Primary completion15 Mar 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Geriatric Patient Care ImprovementStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: Anaesthesia depth monitoring according to hemodynamic values Group 2: Anaesthesia depth monitoring according to numeric BIS values (numbers between 40 to 60 is aimed) Group 3: Anaesthesia depth monitoring according to DSA function (avoiding obvious burst supression and keeping alpha band in high frequency)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aslıhan Güleç
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aslıhan Güleç, Gazi University
- Investigators
- Zerrin Ozkose Satirlar, Professor, Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844279
- Sponsor's protocol ID
- Gazi-2024 -1816
- Status last verified
- Feb 2025
- First submitted
- 9 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All IPD that underlie results in the publication
Publications
Purdon PL, Sampson A, Pavone KJ, Brown EN. Clinical Electroencephalography for Anesthesiologists: Part I: Background and Basic Signatures. Anesthesiology. 2015 Oct;123(4):937-60. doi: 10.1097/ALN.0000000000000841.
PubMed 26275092Aldecoa C, Bettelli G, Bilotta F, Sanders RD, Audisio R, Borozdina A, Cherubini A, Jones C, Kehlet H, MacLullich A, Radtke F, Riese F, Slooter AJ, Veyckemans F, Kramer S, Neuner B, Weiss B, Spies CD. European Society of Anaesthesiology evidence-based and consensus-based guideline on postoperative delirium. Eur J Anaesthesiol. 2017 Apr;34(4):192-214. doi: 10.1097/EJA.0000000000000594.
PubMed 28187050Wildes TS, Mickle AM, Ben Abdallah A, Maybrier HR, Oberhaus J, Budelier TP, Kronzer A, McKinnon SL, Park D, Torres BA, Graetz TJ, Emmert DA, Palanca BJ, Goswami S, Jordan K, Lin N, Fritz BA, Stevens TW, Jacobsohn E, Schmitt EM, Inouye SK, Stark S, Lenze EJ, Avidan MS; ENGAGES Research Group. Effect of Electroencephalography-Guided Anesthetic Administration on Postoperative Delirium Among Older Adults Undergoing Major Surgery: The ENGAGES Randomized Clinical Trial. JAMA. 2019 Feb 5;321(5):473-483. doi: 10.1001/jama.2018.22005.
PubMed 30721296Chen YC, Hung IY, Hung KC, Chang YJ, Chu CC, Chen JY, Ho CH, Yu CH. Incidence change of postoperative delirium after implementation of processed electroencephalography monitoring during surgery: a retrospective evaluation study. BMC Anesthesiol. 2023 Oct 4;23(1):330. doi: 10.1186/s12871-023-02293-9.
PubMed 37794315Shao YR, Kahali P, Houle TT, Deng H, Colvin C, Dickerson BC, Brown EN, Purdon PL. Low Frontal Alpha Power Is Associated With the Propensity for Burst Suppression: An Electroencephalogram Phenotype for a "Vulnerable Brain". Anesth Analg. 2020 Nov;131(5):1529-1539. doi: 10.1213/ANE.0000000000004781.
PubMed 33079876Fritz BA, Kalarickal PL, Maybrier HR, Muench MR, Dearth D, Chen Y, Escallier KE, Ben Abdallah A, Lin N, Avidan MS. Intraoperative Electroencephalogram Suppression Predicts Postoperative Delirium. Anesth Analg. 2016 Jan;122(1):234-42. doi: 10.1213/ANE.0000000000000989.
PubMed 26418126Monk TG, Weldon BC, Garvan CW, Dede DE, van der Aa MT, Heilman KM, Gravenstein JS. Predictors of cognitive dysfunction after major noncardiac surgery. Anesthesiology. 2008 Jan;108(1):18-30. doi: 10.1097/01.anes.0000296071.19434.1e.
PubMed 18156878
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geriatrik Hasta Grubunda Anestezi Derinliği Monitörizasyonlarının Postoperatif Derlenme ve Bilişsel Fonksiyonlara Etkileri
- ClinicalTrials.gov ID
- NCT06844279
- Acronym / sponsor ID
- Gazi-2024 -1816
- Keywords
- anaesthesia depth monitoring, geriatric, density spectral array, bispectral index, burst supression, postoperative delirium
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Aslıhan GüleçUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 25 Feb 2025 (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.
This study will be conducted on patients aged 65 and older scheduled for surgery due to lumbar or cervical disc herniation. General anesthesia is routinely used for these types of surgeries in the hospital. In patients receiving general anesthesia, anesthesia depth monitoring is performed.
As part of the study, a preoperative anesthesia evaluation will be conducted, which will include age, weight, height, comorbidities, regularly used medications, previous surgical or anesthesia experiences, nutritional habits, mental status, and daily activity levels.
On the day of surgery, upon arrival in the operating room, the following will be measured and recorded:
- Blood pressure using a non-invasive blood pressure monitor
- Heart rate and rhythm via electrocardiogram (ECG)
- Blood oxygen level with a pulse oximeter
- Anesthesia depth using a forehead-applied sensor
All monitoring procedures are non-invasive and painless. Following the placement of these monitoring devices and initial measurements, anesthesia induction and surgery will commence. Throughout surgery, blood pressure, heart rate, and brain activity will be continuously recorded. After the surgical procedure, anesthesia emergence and mental status will be assessed. Preoperative evaluation data and intraoperative recordings will be used solely for research purposes, with patient identity information remaining confidential.
Detailed description
Perioperative cognitive decline and delirium occur more frequently in the geriatric population undergoing surgery. International guidelines recommend monitoring anesthesia depth to reduce the risk of postoperative cognitive dysfunction. Anesthesia depth is commonly measured using non-invasive electroencephalography (EEG)-based methods, such as the Bispectral Index (BIS).
Previous studies have predominantly utilized processed EEG monitors that generate numerical values for tracking anesthesia depth. However, in this study, anesthesia depth will be monitored using both the standard numerical BIS index and the Density Spectral Array (DSA) mode, an advanced feature of the BIS device. To date, no studies have simultaneously examined BIS and DSA modes in relation to cognitive function and the recovery process.
The use of advanced monitoring techniques may serve as a valuable resource for future research, particularly in optimizing anesthetic management for geriatric patients with reduced cognitive reserve. This study aims to evaluate the effects of different intraoperative anesthesia depth monitoring approaches, including hemodynamic monitoring, numerical BIS values, and DSA functions. The primary objective is to determine the optimal anesthesia monitoring strategy that minimizes intraoperative hypotension, burst suppression, and postoperative delirium.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Group 1: Anaesthesia depth monitoring according to hemodynamic values Group 2: Anaesthesia depth monitoring according to numeric BIS values (numbers between 40 to 60 is aimed) Group 3: Anaesthesia depth monitoring according to DSA function (avoiding obvious burst supression and keeping alpha band in high frequency)
| Arm | Type | Receives |
|---|---|---|
| Hemodynamic-Guided Group | Active comparator | Other: Control Group: Standard Hemodynamic MonitoringAnesthesia depth monitoring will be managed according to hemodynamic parameters, primarily avoiding hypotension. |
| BIS-Guided Group | Active comparator | Device: Processed Electroencephalogram (BIS Index)Anaesthesia depth monitoring according to numeric BIS index values |
| DSA-Guided Group | Active comparator | Device: Processed Electroencephalogram (DSA Mode)Anesthesia depth monitoring using the Density Spectral Array (DSA) function of the BIS monitor. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 65 years and older
- Elective spinal surgeries
- ASA status I-III
Key exclusion criteria (4 listed)
- Emergent surgeries
- ASA status IV-V
- Prediagnosed delirium and or dementia
- Inability to give consent
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 |
|---|---|---|
| Control Group: Standard Hemodynamic MonitoringAnesthesia depth monitoring based on hemodynamic values without additional processed EEG guidance. | Other | Hemodynamic-Guided Group |
| Processed Electroencephalogram (BIS Index)Anaesthesia depth monitoring according to numeric BIS index values. | Device | BIS-Guided Group |
| Processed Electroencephalogram (DSA Mode)Anaesthesia depth monitoring according to density spectral array functions | Device | DSA-Guided Group |
Primary outcome
Ratio of Burst Suppression
Time frame: Intraoperative (continuously recorded from anesthesia induction to emergence)
The burst suppression ratio (BSR) will be calculated as the percentage of total anesthesia time spent in burst suppression, as measured by processed electroencephalography (EEG). A higher BSR has been associated with worse postoperative cognitive outcomes.
Time of Burst Suppression
Time frame: Intraoperative (continuously recorded from anesthesia induction to emergence)
Anesthesia time spent in burst suppression (BS), as measured by processed electroencephalography (EEG). A higher BS time has been associated with worse postoperative cognitive outcomes.
Intraoperative Hypotension Incidence
Time frame: Intraoperative (assessed continuously throughout surgery)
Intraoperative hypotension will be measured in 5-minute intervals. Hypotension is a mean arterial pressure (MAP) below 60 mmHg. The episodes of hypotension at any point during surgery will be recorded.
Alpha Band Preservation or Loss
Time frame: Intraoperative (measured continuously from anesthesia induction to emergence)
Alpha band activity (8-12 Hz) in the frontal lobe will be evaluated to determine whether it is preserved or lost during general anesthesia. Alpha band preservation is associated with optimal anesthesia depth and cognitive function preservation, while loss of alpha band activity is linked to increased postoperative cognitive impairment.
5 secondary outcomes
Incidence of Postoperative Delirium Assessed via CAM Scale
Time frame: Postoperative (assessed at 6, 24, and 48 hours after surgery)
Total Intraoperative Propofol Consumption
Time frame: Intraoperative
Total Intraoperative Sevoflurane Consumption
Time frame: Intraoperative
Total Intraoperative Remifentanil Consumption
Time frame: Intraoperative
Total Intraoperative Vasopressor Consumption
Time frame: Intraoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Results publication: PubMed 26275092Purdon PL, Sampson A, Pavone KJ, Brown EN. Clinical Electroencephalography for Anesthesiologists: Part I: Background and Basic Signatures. Anesthesiology. 2015 Oct;123(4):937-60. doi: 10.1097/ALN.0000000000000841.
- Results publication: PubMed 28187050Aldecoa C, Bettelli G, Bilotta F, Sanders RD, Audisio R, Borozdina A, Cherubini A, Jones C, Kehlet H, MacLullich A, Radtke F, Riese F, Slooter AJ, Veyckemans F, Kramer S, Neuner B, Weiss B, Spies CD. European Society of Anaesthesiology evidence-based and consensus-based guideline on postoperative delirium. Eur J Anaesthesiol. 2017 Apr;34(4):192-214. doi: 10.1097/EJA.0000000000000594.
- Results publication: PubMed 30721296Wildes TS, Mickle AM, Ben Abdallah A, Maybrier HR, Oberhaus J, Budelier TP, Kronzer A, McKinnon SL, Park D, Torres BA, Graetz TJ, Emmert DA, Palanca BJ, Goswami S, Jordan K, Lin N, Fritz BA, Stevens TW, Jacobsohn E, Schmitt EM, Inouye SK, Stark S, Lenze EJ, Avidan MS; ENGAGES Research Group. Effect of Electroencephalography-Guided Anesthetic Administration on Postoperative Delirium Among Older Adults Undergoing Major Surgery: The ENGAGES Randomized Clinical Trial. JAMA. 2019 Feb 5;321(5):473-483. doi: 10.1001/jama.2018.22005.
- Results publication: PubMed 37794315Chen YC, Hung IY, Hung KC, Chang YJ, Chu CC, Chen JY, Ho CH, Yu CH. Incidence change of postoperative delirium after implementation of processed electroencephalography monitoring during surgery: a retrospective evaluation study. BMC Anesthesiol. 2023 Oct 4;23(1):330. doi: 10.1186/s12871-023-02293-9.
- Results publication: PubMed 33079876Shao YR, Kahali P, Houle TT, Deng H, Colvin C, Dickerson BC, Brown EN, Purdon PL. Low Frontal Alpha Power Is Associated With the Propensity for Burst Suppression: An Electroencephalogram Phenotype for a "Vulnerable Brain". Anesth Analg. 2020 Nov;131(5):1529-1539. doi: 10.1213/ANE.0000000000004781.
- Results publication: PubMed 26418126Fritz BA, Kalarickal PL, Maybrier HR, Muench MR, Dearth D, Chen Y, Escallier KE, Ben Abdallah A, Lin N, Avidan MS. Intraoperative Electroencephalogram Suppression Predicts Postoperative Delirium. Anesth Analg. 2016 Jan;122(1):234-42. doi: 10.1213/ANE.0000000000000989.
- Results publication: PubMed 18156878Monk TG, Weldon BC, Garvan CW, Dede DE, van der Aa MT, Heilman KM, Gravenstein JS. Predictors of cognitive dysfunction after major noncardiac surgery. Anesthesiology. 2008 Jan;108(1):18-30. doi: 10.1097/01.anes.0000296071.19434.1e.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in the publication
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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.
Zerrin Ozkose Satirlar, Professor study director
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Processed Electroencephalogram (BIS Index) and Processed Electroencephalogram (DSA Mode) in people with Geriatric Patient Care Improvement and Postoperative Delirium (POD), run by Aslıhan Güleç 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 28 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aslihan Gulec Kilic, MD (+905072709000, aslihangulec@gazi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of Burst Suppression (time frame: Intraoperative (continuously recorded from anesthesia induction to emergence)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06844279, which also lists 7 linked publications.
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 28 Feb 2025.