- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07266727
Anesthetic Agent Titration With EEG Wave Analysis
December 14, 2025 updated by: Şeyma Çelik, Marmara University
Anesthetic Agent Titration With EEG Wave Analysis: Does it Improve Postoperative Recovery?
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.
Study Overview
Status
Completed
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.
Study Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey (Türkiye)
- Marmara University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
65 years and older patients
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Postoperative Recovery Quality
Time Frame: 24 hours
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Data of QoR-15 score in the preoperative period and at the 24th hour postoperatively The 15-item Quality of Recovery (QoR-15) score is a patient-reported outcome measure assessing postoperative recovery.
Scores range from 0 to 150, with higher scores indicating better quality of recovery.
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24 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Postoperative Delirium Evaluation
Time Frame: 48 hours
|
Nu-DESC score in the preoperative period and 48-hour postoperative period The Nursing Delirium Screening Scale (Nu-DESC) is a clinician-rated tool used to screen for delirium.
The total score ranges from 0 to 10, with higher scores indicating a worse outcome (greater severity or presence of delirium).
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48 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 4, 2025
Primary Completion (Actual)
November 4, 2025
Study Completion (Actual)
November 4, 2025
Study Registration Dates
First Submitted
November 24, 2025
First Submitted That Met QC Criteria
November 24, 2025
First Posted (Estimated)
December 5, 2025
Study Record Updates
Last Update Posted (Actual)
December 19, 2025
Last Update Submitted That Met QC Criteria
December 14, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09.2025.25-0113
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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