Geriatric Patient Care ImprovementNCT07266727
Anesthetic Agent Titration With EEG Wave Analysis
An observational study of Geriatric Patient Care Improvement and EEG Data Analysis, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Geriatric Patient Care Improvement, EEG Data Analysis
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Mar 2025to 4 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: 65 years and older patients
Who may be able to join
- Patients aged 65 and over
- Elective patients undergoing general anesthesia
- EEG monitoring
Who cannot join
- Pediatric patients
- Patients not giving written consent
- Emergency cases
- History of seizure
- Intracranial surgeries
- Alcohol and substance addiction
- Severe cognitive impairment (dementia, Alzheimer's)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Keywords
- electroencephalogram, postoperative delirium, geriatric patients
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Recovery Quality
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.
Measured: 24 hours
Secondary outcomes (1)
Postoperative Delirium Evaluation
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).
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start4 Mar 2025
- Primary completion4 Nov 2025
- Study completion4 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric Patient Care ImprovementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şeyma Çelik, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266727
- Sponsor's protocol ID
- 09.2025.25-0113
- Status last verified
- Dec 2025
- First submitted
- 24 Nov 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthetic Agent Titration With EEG Wave Analysis: Does it Improve Postoperative Recovery?
- ClinicalTrials.gov ID
- NCT07266727
- Acronym / sponsor ID
- 09.2025.25-0113
- Keywords
- electroencephalogram, postoperative delirium, geriatric patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 4 Nov 2025 (actual)
- Study completion
- 4 Nov 2025 (actual)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 65 years and older patients
Key inclusion criteria (3 listed)
- Patients aged 65 and over
- Elective patients undergoing general anesthesia
- EEG monitoring
Key exclusion criteria (7 listed)
- Pediatric patients
- Patients not giving written consent
- Emergency cases
- History of seizure
- Intracranial surgeries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Postoperative Delirium Evaluation
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Geriatric Patient Care Improvement and EEG Data Analysis, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Recovery Quality (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.