Obesity (BMI>30)NCT07877090
Frontal EEG Dynamics During Anesthesia in Patients With Obesity and Normal Weight
An observational study of Obesity (BMI>30) and General Anesthesia, run by Duzce University at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to compare frontal electroencephalographic (EEG) spectral dynamics between patients with obesity and normal weight undergoing general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity (BMI>30), General Anesthesia
- What is being tested?
- Frontal Electroencephalography Monitoring
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Oct 2026to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ClinicalTrials.gov için burada nereden ve hangi hasta grubundan katılımcıların seçileceğini tarif etmeliyiz. Şöyle yazalım: Study Population Description: The study population will consist of adult patients aged 18-65 years undergoing elective surgery under general anesthesia at Düzce University Research and Application Hospital. Eligible participants will be prospectively enrolled and classified into two groups according to body mass index (BMI): a normal-weight group (BMI 18.5-24.9 kg/m²) and an obesity group (BMI ≥30 kg/m²). All participants will undergo propofol induction and continuous frontal EEG monitoring during anesthesia. Anesthetic management will be determined by the attending anesthesiologist according to routine clinical practice and will not be modified for study purposes.
Who may be able to join
- Adults aged 18-65 years
- Scheduled for elective surgery under general anesthesia
- American Society of Anesthesiologists (ASA) physical status I-III
- General anesthesia induction performed with propofol
- Availability of continuous frontal EEG monitoring (SedLine) during anesthesia
- BMI 18.5-24.9 kg/m² for the normal-weight group or BMI ≥30 kg/m² for the obesity group
- Ability to provide written informed consent
Who cannot join
- - BMI 25.0-29.9 kg/m²
- History of epilepsy or seizure disorder
- Known major neurological disease that may affect EEG activity
- Altered level of consciousness before anesthesia
- Regular use of antiepileptic medications or other drugs known to substantially affect EEG activity
- Emergency surgery
Show all 11Show fewer
- Pregnancy
- Skin lesions, infection, or other conditions of the forehead preventing appropriate placement of the EEG sensor
- Inability to obtain an adequate-quality EEG recording because of technical failure or excessive artifacts
- Requirement for substantial deviation from the planned routine anesthetic management that prevents standardized EEG assessment
- Refusal to participate or inability to provide written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Düzce University Research and Application Hospital
Düzce, Düzce
gizem demir şenoğlu, 05059313588, gizem123demir@hotmail.com
About this study
Official title: Frontal EEG Spectral Dynamics During General Anesthesia in Obese and Normal-Weight Patients: A Prospective Observational Study
This prospective observational study aims to compare frontal electroencephalographic (EEG) spectral dynamics between patients with obesity and normal weight undergoing general anesthesia. The primary objective is to evaluate whether changes in frontal alpha power around propofol-induced loss of consciousness differ between the two BMI groups. Secondary objectives include comparing changes in delta power, the alpha/delta power ratio, and frontal alpha asymmetry around loss of consciousness, as well as evaluating EEG spectral dynamics throughout the intraoperative period. Anesthetic management will be determined by the attending anesthesiologist according to routine clinical practice, without intervention by the study investigators.
- Conditions
- Obesity (BMI>30), General Anesthesia
- Being tested
- Frontal Electroencephalography Monitoring
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frontal Electroencephalography MonitoringOther
Frontal EEG activity will be continuously recorded using a non-invasive EEG monitoring system during induction and maintenance of general anesthesia. EEG monitoring will not alter routine anesthetic management. Anesthetic agents, doses, and maintenance techniques will be determined by the attending anesthesiologist according to routine clinical practice. Recorded EEG data will be analyzed for spectral parameters, including alpha power, delta power, alpha/delta power ratio, spectral edge frequency, and frontal alpha asymmetry.
| Study group | Role | What they receive |
|---|---|---|
| Obesity Group | Participants with BMI ≥30 kg/m² undergoing elective surgery under general anesthesia. Receives: Other: Frontal Electroencephalography Monitoring | |
| Normal Weight Group | Participants with BMI 18.5-24.9 kg/m² undergoing elective surgery under general anesthesia. Receives: Other: Frontal Electroencephalography Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Bilateral Spectral Edge Frequency Between BMI Groups During General Anesthesia
Bilateral spectral edge frequency (SEF) derived from frontal EEG recordings will be compared between patients with obesity and normal weight during general anesthesia. SEF will be evaluated as a quantitative measure of EEG spectral frequency distribution while anesthetic depth is maintained within a target Patient State Index (PSI) range of 30-50. Right and left SEF measurements will be evaluated bilaterally.
Measured: From induction of general anesthesia until the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start21 Oct 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity (BMI>30)Studies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gizem Demir Şenoğlu, Duzce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877090
- Sponsor's protocol ID
- 2026/eeg
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In accordance with the law on the protection of patients' personal data, such information will be shared if requested by the relevant authorities.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frontal EEG Spectral Dynamics During General Anesthesia in Obese and Normal-Weight Patients: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07877090
- Acronym / sponsor ID
- 2026/eeg
- Conditions
- Obesity (BMI>30), General Anesthesia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 21 Oct 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 16 Oct 2026 (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.
This prospective observational study aims to compare frontal electroencephalographic (EEG) spectral dynamics between patients with obesity and normal weight undergoing general anesthesia. The primary objective is to evaluate whether changes in frontal alpha power around propofol-induced loss of consciousness differ between the two BMI groups. Secondary objectives include comparing changes in delta power, the alpha/delta power ratio, and frontal alpha asymmetry around loss of consciousness, as well as evaluating EEG spectral dynamics throughout the intraoperative period. Anesthetic management will be determined by the attending anesthesiologist according to routine clinical practice, without intervention by the study investigators.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obesity Group | – | Other: Frontal Electroencephalography MonitoringParticipants with BMI ≥30 kg/m² undergoing elective surgery under general anesthesia. |
| Normal Weight Group | – | Other: Frontal Electroencephalography MonitoringParticipants with BMI 18.5-24.9 kg/m² undergoing elective surgery under general anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ClinicalTrials.gov için burada nereden ve hangi hasta grubundan katılımcıların seçileceğini tarif etmeliyiz. Şöyle yazalım: Study Population Description: The study population will consist of adult patients aged 18-65 years undergoing elective surgery under general anesthesia at Düzce University Research and Application Hospital. Eligible participants will be prospectively enrolled and classified into two groups according to body mass index (BMI): a normal-weight group (BMI 18.5-24.9 kg/m²) and an obesity group (BMI ≥30 kg/m²). All participants will undergo propofol induction and continuous frontal EEG monitoring during anesthesia. Anesthetic management will be determined by the attending anesthesiologist according to routine clinical practice and will not be modified for study purposes.
Key inclusion criteria (7 listed)
- Adults aged 18-65 years
- Scheduled for elective surgery under general anesthesia
- American Society of Anesthesiologists (ASA) physical status I-III
- General anesthesia induction performed with propofol
- Availability of continuous frontal EEG monitoring (SedLine) during anesthesia
Key exclusion criteria (11 listed)
- - BMI 25.0-29.9 kg/m²
- History of epilepsy or seizure disorder
- Known major neurological disease that may affect EEG activity
- Altered level of consciousness before anesthesia
- Regular use of antiepileptic medications or other drugs known to substantially affect EEG activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frontal Electroencephalography MonitoringFrontal EEG activity will be continuously recorded using a non-invasive EEG monitoring system during induction and maintenance of general anesthesia. EEG monitoring will not alter routine anesthetic management. Anesthetic agents, doses, and maintenance techniques will be determined by the attending anesthesiologist according to routine clinical practice. Recorded EEG data will be analyzed for spectral parameters, including alpha power, delta power, alpha/delta power ratio, spectral edge frequency, and frontal alpha asymmetry. | Other | Normal Weight Group, Obesity Group |
Primary outcome
Difference in Bilateral Spectral Edge Frequency Between BMI Groups During General Anesthesia
Time frame: From induction of general anesthesia until the end of surgery
Bilateral spectral edge frequency (SEF) derived from frontal EEG recordings will be compared between patients with obesity and normal weight during general anesthesia. SEF will be evaluated as a quantitative measure of EEG spectral frequency distribution while anesthetic depth is maintained within a target Patient State Index (PSI) range of 30-50. Right and left SEF measurements will be evaluated bilaterally.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No. In accordance with the law on the protection of patients' personal data, such information will be shared if requested by the relevant authorities.
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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.
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 Obesity (BMI>30) and General Anesthesia, run by Duzce 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 7 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact gizem demir şenoğlu, ass. prof (05059313588, gizem123demir@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Bilateral Spectral Edge Frequency Between BMI Groups During General Anesthesia (time frame: From induction of general anesthesia until the end of surgery). 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 22 Oct 2026.