Burst Suppressions in Diabetic Elderly

NCT07037186 | Active Not Recruiting

• 1 other identifier: 30-2024
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus; Geriatric; General Anaesthesia; Electroencephalography; Oxymetry

Keywords

postoperative delirium; elderly; electroencephalography; burst suppression; diabetes mellitus; general anesthesia

Outcome Measures

Primary Outcomes (1)

• burst-suppression

  Burst suppression amount recorded during EEG monitorization under general anesthesia

  Perioperative

Secondary Outcomes (1)

• delirium

  Perioperative

Study Arms (3)

DM-OAD

Diabetic patients who are under oral anridiabetic medcation and not used insulin regimens

Device: Electroencephalogram

DM-Insulin

Diabetic patients under insulin regimen

Device: Electroencephalogram

Non-DM

Patients without diabetes mellitus

Device: Electroencephalogram

Interventions

Electroencephalogram DEVICE

All patients will receive intraoperative electroencephalography monitorization during general anesthesia.

DM-Insulin; DM-OAD; Non-DM

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Elderly patients receiving general anesthesia

You may qualify if:

• 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

You may not qualify if:

• \) 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

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, sultangazi, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 37626505 BACKGROUND

• Shang 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.

  PMID: 38335150 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Emergence Delirium

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Berna Caliskan, MD

  Haseki Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 25, 2025
• Study Start: December 1, 2024
• Primary Completion: July 28, 2025
• Study Completion: August 15, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)