Diabetes MellitusNCT07037186
Burst Suppressions in Diabetic Elderly
An observational study of Diabetes Mellitus and Geriatric, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This observational study aims to learn about the effects of diabetes mellitus in intraoperative electroencephalography (EEG) of elderly patients receiving general anesthesia. The main question it seeks to answer is: Is there a relation between preoperative diabetes, intraoperative electroencephalogram suppression… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Geriatric, General Anaesthesia
- What is being tested?
- Electroencephalogram
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 15 Aug 2025
- How long will I take part?
- 2 Days
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Older adult
Study population: Elderly patients receiving general anesthesia
Who may be able to join
- Patients over the age of 65 undergoing ASA I-IV receiving general anaesthesia
- All elective surgery patients who are not laparoscopic and last longer than 30 minutes
Who cannot join
- 1) American Society of Anesthesiologists (ASA) grade V or VI
- Whether the surgery is cranial or laparoscopic
- Preoperative neuropsychiatric (dementia, epilepsy, etc.) disease or drug use
- Previous cranial surgery or known vertebrobasilar insufficiency, carotid stenosis
- Those with a pain score above 4 in the postoperative evaluation unit (PACU)
- Patients with a 15% decrease in cerebral oxygenation from onset in oximetry monitoring during follow-up
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- Patients with bleeding greater than 20% of total body volume during follow-up
- Patients with a decrease of more than 20% from their baseline systolic value (based on follow-up in the service) during follow-up
- Those with hypercarbia or hypocarbia due to intraoperative ventilation insufficiency
- Patients whose PSI value is reduced to a depth of 25, which is sufficient for anaesthesia, with anaesthetic drugs administered during anaesthesia induction or maintenance
- Presence of preoperative cognitive dysfunction
- Patients requiring postoperative intubation and intensive care follow-up
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haseki Training and Research Hospital
Istanbul, Sultangazi
About this study
Official title: Impact of Diabetes on Burst-Suppressions During Intraoperative EEG in Elderly Patients: Correlation With Postoperative Delirium
This observational study aims to learn about the effects of diabetes mellitus in intraoperative electroencephalography (EEG) of elderly patients receiving general anesthesia. The main question it seeks to answer is:
Is there a relation between preoperative diabetes, intraoperative electroencephalogram suppression ratio, and postoperative delirium?
Participants aged over 65, receiving general anesthesia as part of their anesthesia plan for surgery of any kind, will be monitored with EEG and cerebral oximetry intraoperatively to record burst suppressions and questioned for delirium for 48 hours postoperatively.
Read the detailed description
3 different patient groups will be observed: those who are diagnosed with diabetes and use oral antidiabetics, those who receive insulin therapy with a diagnosis of diabetes, and patients whose preoperative fasting glucose values are confirmed to be normal without a diagnosis of diabetes.
Patients over 65 who are scheduled for any surgery requiring general anesthesia for at least 30 minutes will be evaluated to detect their basal cognition status with a mini-cognition test and a preoperative anesthesia examination. In addition to routine monitoring, this patient group will also be monitored with electroencephalogram and cerebral oximetry.
Anesthesia induction and maintenance for each patient are applied according to the values here. In the maintenance of anesthesia, sevoflurane will be regulated according to 0.7-1 MAC (adjusted for age), and remifentanil infusion will be regulated according to PSI. Postoperative analgesia will be achieved with tramadol 1 mg/kg and Parol 10 mg/kg (IV) with a target pain score below 4. Each patient will be evaluated with a NUDESC score as a delirium score in the postoperative PACU and during 48 hours in the ward. Values such as suppression time and ratio, the subject of study in EEG recordings during anesthesia, can only be seen by transferring them to the computer with a transfer cable, so the evaluations will be blind. All data transfers will be done after the 48th hour.
- Being tested
- Electroencephalogram
- Keywords
- postoperative delirium, elderly, electroencephalography, burst suppression, diabetes mellitus, general anesthesia
- Medical subject headings
- Diabetes Mellitus, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroencephalogramDevice
All patients will receive intraoperative electroencephalography monitorization during general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| DM-OAD | Diabetic patients who are under oral anridiabetic medcation and not used insulin regimens Receives: Device: Electroencephalogram | |
| DM-Insulin | Diabetic patients under insulin regimen Receives: Device: Electroencephalogram | |
| Non-DM | Patients without diabetes mellitus Receives: Device: Electroencephalogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
burst-suppression
Burst suppression amount recorded during EEG monitorization under general anesthesia
Measured: Perioperative
Secondary outcomes (1)
delirium
postoperative delirium scanned with the nursing delirium screening scale (NUDESC)
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start1 Dec 2024
- Primary completion28 Jul 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- 80 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Berna Caliskan, MD, Study chair, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037186
- Sponsor's protocol ID
- 30-2024
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang X, Li A, Wang S, Wang T, Liu T, Wang Y, Fu J, Zhao G, Yang Q, Dong H. Differences in the EEG Power Spectrum and Cross-Frequency Coupling Patterns between Young and Elderly Patients during Sevoflurane Anesthesia. Brain Sci. 2023 Jul 31;13(8):1149. doi: 10.3390/brainsci13081149.
PubMed 37626505Shang Z, Jiang Y, Fang P, Zhu W, Guo J, Li L, Liang Y, Zhang S, Ma S, Mei B, Fan Y, Xie Z, Shen Q, Liu X. The Association of Preoperative Diabetes With Postoperative Delirium in Older Patients Undergoing Major Orthopedic Surgery: A Prospective Matched Cohort Study. Anesth Analg. 2024 May 1;138(5):1031-1042. doi: 10.1213/ANE.0000000000006893. Epub 2024 Feb 9.
PubMed 38335150
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Diabetes on Burst-Suppressions During Intraoperative EEG in Elderly Patients: Correlation With Postoperative Delirium
- ClinicalTrials.gov ID
- NCT07037186
- Acronym / sponsor ID
- 30-2024
- Keywords
- postoperative delirium, elderly, electroencephalography, burst suppression, diabetes mellitus, general anesthesia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 28 Jul 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 25 Jun 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 observational study aims to learn about the effects of diabetes mellitus in intraoperative electroencephalography (EEG) of elderly patients receiving general anesthesia. The main question it seeks to answer is:
Is there a relation between preoperative diabetes, intraoperative electroencephalogram suppression ratio, and postoperative delirium?
Participants aged over 65, receiving general anesthesia as part of their anesthesia plan for surgery of any kind, will be monitored with EEG and cerebral oximetry intraoperatively to record burst suppressions and questioned for delirium for 48 hours postoperatively.
Detailed description
3 different patient groups will be observed: those who are diagnosed with diabetes and use oral antidiabetics, those who receive insulin therapy with a diagnosis of diabetes, and patients whose preoperative fasting glucose values are confirmed to be normal without a diagnosis of diabetes.
Patients over 65 who are scheduled for any surgery requiring general anesthesia for at least 30 minutes will be evaluated to detect their basal cognition status with a mini-cognition test and a preoperative anesthesia examination. In addition to routine monitoring, this patient group will also be monitored with electroencephalogram and cerebral oximetry.
Anesthesia induction and maintenance for each patient are applied according to the values here. In the maintenance of anesthesia, sevoflurane will be regulated according to 0.7-1 MAC (adjusted for age), and remifentanil infusion will be regulated according to PSI. Postoperative analgesia will be achieved with tramadol 1 mg/kg and Parol 10 mg/kg (IV) with a target pain score below 4. Each patient will be evaluated with a NUDESC score as a delirium score in the postoperative PACU and during 48 hours in the ward. Values such as suppression time and ratio, the subject of study in EEG recordings during anesthesia, can only be seen by transferring them to the computer with a transfer cable, so the evaluations will be blind. All data transfers will be done after the 48th hour.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DM-OAD | – | Device: ElectroencephalogramDiabetic patients who are under oral anridiabetic medcation and not used insulin regimens |
| DM-Insulin | – | Device: ElectroencephalogramDiabetic patients under insulin regimen |
| Non-DM | – | Device: ElectroencephalogramPatients without diabetes mellitus |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Elderly patients receiving general anesthesia
Key inclusion criteria (2 listed)
- Patients over the age of 65 undergoing ASA I-IV receiving general anaesthesia
- All elective surgery patients who are not laparoscopic and last longer than 30 minutes
Key exclusion criteria (12 listed)
- 1) American Society of Anesthesiologists (ASA) grade V or VI
- Whether the surgery is cranial or laparoscopic
- Preoperative neuropsychiatric (dementia, epilepsy, etc.) disease or drug use
- Previous cranial surgery or known vertebrobasilar insufficiency, carotid stenosis
- Those with a pain score above 4 in the postoperative evaluation unit (PACU)
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 |
|---|---|---|
| ElectroencephalogramAll patients will receive intraoperative electroencephalography monitorization during general anesthesia. | Device | DM-Insulin, DM-OAD, Non-DM |
Primary outcome
burst-suppression
Time frame: Perioperative
Burst suppression amount recorded during EEG monitorization under general anesthesia
1 secondary outcome
delirium
Time frame: Perioperative
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 25 Jun 2025.
- Results publication: PubMed 37626505Zhang X, Li A, Wang S, Wang T, Liu T, Wang Y, Fu J, Zhao G, Yang Q, Dong H. Differences in the EEG Power Spectrum and Cross-Frequency Coupling Patterns between Young and Elderly Patients during Sevoflurane Anesthesia. Brain Sci. 2023 Jul 31;13(8):1149. doi: 10.3390/brainsci13081149.
- Results publication: PubMed 38335150Shang Z, Jiang Y, Fang P, Zhu W, Guo J, Li L, Liang Y, Zhang S, Ma S, Mei B, Fan Y, Xie Z, Shen Q, Liu X. The Association of Preoperative Diabetes With Postoperative Delirium in Older Patients Undergoing Major Orthopedic Surgery: A Prospective Matched Cohort Study. Anesth Analg. 2024 May 1;138(5):1031-1042. doi: 10.1213/ANE.0000000000006893. Epub 2024 Feb 9.
- Individual participant dataSharing planned: No
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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.
Berna Caliskan, MD study chair
Haseki Training and Research Hospital
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 Diabetes Mellitus and Geriatric, run by Haseki 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 2 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 25 Jun 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?
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?
burst-suppression (time frame: Perioperative). 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 NCT07037186, which also lists 2 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 25 Jun 2025.