Anesthetic Agent Titration With EEG Wave Analysis

NCT ID: NCT07266727

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-04
• Study Completion Date: 2025-11-04

Brief Summary

Several studied shown that when general anesthesia is applied under BIS guidance, anesthetic doses are reduced. Additionally it has been found that the risk of postoperative delirium (POD) is reduced and postoperative recovery is accelerated compared to deeper general anesthesia. Current guidelines recommend EEG-based monitoring techniques to prevent postoperative neurocognitive disorders. In clinical practice anesthetic depth is assessed by the patient's autonomic responses to surgical stimulation (pupil diameter, tear, blood pressure and heart rate increase, etc.), the amount of anesthetic gas measured from the expiratory air, and the interpretation of EEG waves and numerical values calculated from these waves (bispactral index, entropy, patient safety index, etc.). The doses of intravenous anesthetic agents used for anesthesia induction are traditionally determined according to body weight. If general anesthetic doses cannot be titrated appropriately for the patients, especially in the elderly and fragile patient group, serious hemodynamic fluctuations may occur during anesthesia induction. The aim of this study is to investigate whether induction and maintenance of anesthesia using the Kugler EEG Analysis method would improve the quality of postoperative recovery in patients aged 65 years and older.

Detailed Description

Several studied shown that when general anesthesia is applied under BIS guidance, anesthetic doses are reduced. Additionally it has been found that the risk of postoperative delirium (POD) is reduced and postoperative recovery is accelerated compared to deeper general anesthesia. Current guidelines recommend EEG-based monitoring techniques to prevent postoperative neurocognitive disorders. In clinical practice anesthetic depth is assessed by the patient's autonomic responses to surgical stimulation (pupil diameter, tear, blood pressure and heart rate increase, etc.), the amount of anesthetic gas measured from the expiratory air, and the interpretation of EEG waves and numerical values calculated from these waves (bispactral index, entropy, patient safety index, etc.). The doses of intravenous anesthetic agents used for anesthesia induction are traditionally determined according to body weight. If general anesthetic doses cannot be titrated appropriately for the patients, especially in the elderly and fragile patient group, serious hemodynamic fluctuations may occur during anesthesia induction. The aim of this study is to investigate whether induction and maintenance of anesthesia using the Kugler EEG Analysis method would improve the quality of postoperative recovery in patients aged 65 years and older.

Conditions

Geriatric Patient Care Improvement; EEG Data Analysis

Keywords

electroencephalogram; postoperative delirium; geriatric patients

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Conventional Anesthetic Management

Preoperatively, patients were administered the QoR-15 questionnaire and scoring was done according to the Nu-DESC test. Before anesthesia induction, patients will be taught the finger-squeeze test and asked to squeeze the fingers placed in the palm when instructed. If no response is obtained to the test after routine administration of 2 mg/kg propofol and 1.5 mcg/kg fentanyl; 0,5 mg/kg rokuronium administered. Desflurane will be used as maintenance inhalation agent. Hemodynamic parameters and burst suppression time will be recorded at 5-minute intervals during the first 15 minutes after induction and at 15-minute intervals thereafter. At the end of the surgery, the patient will be ready to be sent to the ward with the Modified Aldrete score, and awareness will be assessed with the Modified Brice scale. The QoR-15 questionnaire was repeated at 24 hours postoperatively. For delirium assessment, patients were followed up with the Nu-DESC test for 48 hours postoperatively.

No interventions assigned to this group

Anesthetic Management with Kugler EEG method

Preoperatively, patients were administered the QoR-15 questionnaire and scoring was done according to the Nu-DESC test. Before anesthesia induction, patients will be taught the finger-squeeze test and asked to squeeze the fingers placed in the palm when instructed.Patients were administered propofol according to the Kugler EEG analysis (to be kept C-D level) If no response is obtained, fentanyl 1,5 mcg/kg, 0,5 mg/kg rocuronium administered. Desflurane will be used as maintenance inhalation agent. Hemodynamic parameters and burst suppression time will be recorded at 5-minute intervals during the first 15 minutes after induction and at 15-minute intervals thereafter. At the end of the surgery, the patient ready to be sent to the ward with the Modified Aldrete score, and awareness will be assessed with the Modified Brice scale. The QoR-15 questionnaire repeated at 24 hours postoperatively. For delirium assessment, patients followed up with the Nu-DESC test for 48 hours postoperatively.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients aged 65 and over
• Elective patients undergoing general anesthesia
• EEG monitoring

Exclusion Criteria

• Pediatric patients
• Patients not giving written consent
• Emergency cases
• History of seizure
• Intracranial surgeries
• Alcohol and substance addiction
• Severe cognitive impairment (dementia, Alzheimer's)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Şeyma Çelik

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Marmara University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

09.2025.25-0113

Identifier Type: -

Identifier Source: org_study_id