NCT07037186

Burst Suppressions in Diabetic Elderly

Impact of Diabetes on Burst-Suppressions During Intraoperative EEG in Elderly Patients: Correlation With Postoperative Delirium

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Haseki Training and Research Hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Diabetes Mellitus
• Geriatric
• General Anaesthesia
• Electroencephalography
• Oxymetry

Interventions

Type	Name	Description
DEVICE	Electroencephalogram	All patients will receive intraoperative electroencephalography monitorization during general anesthesia.

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-07-28
• Completion: 2025-08-15
• First posted: 2025-06-25
• Last updated: 2025-06-25

Locations

1 site across 1 country: Turkey (Türkiye)