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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative Recovery Quality
Time Frame: 24 hours
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.
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marmara University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 4, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 4, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 4, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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