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Active, Not Recruiting

NCT Number: NCT07037186

Burst Suppressions in Diabetic Elderly

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electroencephalogram

Device

All patients will receive intraoperative electroencephalography monitorization during general anesthesia.

Primary outcomes

  1. burst-suppression

    Time frame: Perioperative

    Burst suppression amount recorded during EEG monitorization under general anesthesia

Secondary outcomes

  1. delirium

    Time frame: Perioperative

    postoperative delirium scanned with the nursing delirium screening scale (NUDESC)

Sponsors and collaborators

Lead sponsor

Haseki Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 25, 2025
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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