Burst Suppressions in Diabetic Elderly (NCT07037186) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Burst Suppressions in Diabetic Elderly
Turkey (Türkiye)80 participantsStarted 2024-12-01
Plain-language 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 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.
Who can participate
Age range
65 Years
Sex
ALL
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:
* 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
Exclusion Criteria:
* 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
* 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
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.