Seeing the Benefits of Using 4 Channel EEG During the DISE Procedure With SedationNCT06511128
Evaluation of Anesthesia Depth Using 4-channel EEG in Patients Undergoing Drug-induced Sleep Endoscopy (DISE) With Two Different Sedation Methods.
An observational study of Seeing the Benefits of Using 4 Channel EEG During the DISE Procedure With Sedation, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
You will undergo a drug-induced sleep endoscopy procedure. The drugs we use to create routine sedation will be used as medication. During the procedure, your pulse, blood pressure, respiratory rate, blood oxygen level, and alertness will be monitored. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Seeing the Benefits of Using 4 Channel EEG During the DISE Procedure With Sedation
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Mar 2024to 30 May 2025
- How long will I take part?
- 1 Day
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ASA I-II patients between the ages of 18-65 who will undergo sleep endoscopy under sedation in the operating room of Ankara City Hospital Ear Nose and Throat Clinic.
Who may be able to join
- Volunteer patients of both genders and ASA (American Society of Anesthesiology) I-II risk scores, between the ages of 18-65, who will undergo DISE with sedation.
Who cannot join
- Patient unwillingness, being younger than 18 years of age, being older than 65 years of age, patients with ASA score greater than II, pregnant women, drug addicts, alcohol addicts, patients with congestive heart failure, need for intubation, patients receiving oxygen therapy at home, Patients with chronic analgesic use, patients known to be allergic to the anesthetic drugs used, patients with psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Çankaya, 06530
About this study
You will undergo a drug-induced sleep endoscopy procedure. The drugs we use to create routine sedation will be used as medication. During the procedure, your pulse, blood pressure, respiratory rate, blood oxygen level, and alertness will be monitored. Your values will be closely monitored and recorded before, during and after the procedure.
Our study is a study that will not require any changes in the drug-induced sleep endoscopy (DISE) procedure and treatment plan you will undergo. During drug-induced sleep endoscopy (DISE), your measurement values, which we follow in every patient, will be recorded. An adhesive tape will be attached to your forehead area, especially to determine your sleep depth. It will be removed at the end of the procedure.
Read the detailed description
Volunteer patients between the ages of 18-65, both genders and ASA (American Society of Anesthesiology) I-II risk scores, who will undergo DISE with sedation after routine preoperative evaluation under elective conditions, will be included in the study.All patients participating in the study will be explained about the study and possible risks and informed consent will be obtained from the patients.
Exclusion criteria for the study: Patient unwillingness, being younger than 18 years of age, being older than 65 years of age, patients with ASA score greater than II, pregnant women, drug addicts, alcohol addicts, patients with congestive heart failure, need for intubation, patients receiving oxygen therapy at home, Patients with chronic analgesic use, patients known to be allergic to the anesthetic drugs used, patients with psychiatric disorders.
The patient age, weight, BMI, AHI index if any, existing chronic diseases, medications used, whether or not CPAP has been used at home for how many years, duration of the procedure, amount of medications used, whether the airway is intervened or not, hemodynamic(systolic arterial pressure, diastolic arterial pressure, average parameters (e.g. arterial pressure, heart rate, oxygen saturation) will be recorded throughout the procedure.
At the end of the procedure, the patient will be taken to the recovery unit and will be evaluated according to Aldrete criteria and if there is no problem, patient will be sent to the service.The patient\'s wake-up time, recovery time, and possible complications during recovery will be noted and treatment will be planned.
All patients entering the operating room will receive ASA monitoring (non-invasive arterial blood pressure, ECG, oxygen saturation) followed by 4-channel EEG monitoring and baseline values will be noted.After a 4lt/min nasal oxygen cannula is placed, 1 mg midazolam and 50 mcg fentanyl will be given to group I, and then propofol infusion will be started at a dose of 50-100 mcg/kg/min, following an initial dose of 1mg/kg.In group II, infusion will be started at a dose of 0.2-0.7 mcg/kg/h after a loading dose of 1 mg midazolam, 50 mcg fentanyl followed by 1 mcg/kg dexmetedomidine.Anesthesia depth dose adjustment will be made according to the 60-70 PSI value range in the 4-channel EEG. The time to reach the adequate processing level will be recorded.Patients who have reached the target depth of sedation but have hypertension will be given an additional 0.1 mg of glyceryl trinitrate.Decreases of 25% from baseline blood pressure will be considered hypotension and will be treated with fluid boluses and/or followed by IV ephedrine.In the event of apnea or desaturation, airway management techniques such as patient stimulation, increased oxygen supplementation, chin lift, chin thrust maneuver will be applied and noted.
If the pulse rate drops below 50 bpm, treatment with IV 0.5 mg atropine will be considered. While the patient is being sent to the ward, the patient will be asked whether he or she has had a dream, and if so, its content will be noted.
- Keywords
- 4 channel EEG, sedasyon, uyku endoskopisi, propofol, dexmedetomidine
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 |
|---|---|---|
| group created with dexmedetomidine sedation | infusion will be started at a dose of 0.2-0.7 mcg/kg/h after a loading dose of 1 mg midazolam, 50 mcg fentanyl followed by 1 mcg/kg dexmetedomidine. | |
| group created with propofol sedation | After 1 mg midazolam and 50 mcg fentanyl are given, propofol infusion will be started at a dose of 50-100 mcg/kg/min, following an initial dose of 0,5 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of sedation range in 4-channel EEG
Evaluation of sedation depth using 4-channel EEG in drug-induced sleep endoscopy (DISE)"
Measured: from March 2024 to December 2024
Secondary outcomes (1)
Evaluating the effectiveness of different sedation techniques,Snoring situation in the shortest time and effectively,Intraoperative drug consumption,Hemodynamic changes
Evaluating the effectiveness of different sedation techniques,Snoring situation in the shortest time and effectively,Intraoperative drug consumption,Hemodynamic changes
Measured: from March 2024 to December 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start5 Mar 2024
- Primary completion20 Feb 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seeing the Benefits of Using 4 Channel EEG During the DISE Procedure With SedationStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ezgi e Erkılıç, doc doctor, Study director, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511128
- Sponsor's protocol ID
- TABED 1-24-36
- Status last verified
- Jun 2025
- First submitted
- 16 Jul 2024
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Anesthesia Depth Using 4-channel EEG in Patients Undergoing Drug-induced Sleep Endoscopy (DISE) With Two Different Sedation Methods.
- ClinicalTrials.gov ID
- NCT06511128
- Acronym / sponsor ID
- TABED 1-24-36
- Keywords
- 4 channel EEG, sedasyon, uyku endoskopisi, propofol, dexmedetomidine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 19 Jul 2024 (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.
You will undergo a drug-induced sleep endoscopy procedure. The drugs we use to create routine sedation will be used as medication. During the procedure, your pulse, blood pressure, respiratory rate, blood oxygen level, and alertness will be monitored. Your values will be closely monitored and recorded before, during and after the procedure.
Our study is a study that will not require any changes in the drug-induced sleep endoscopy (DISE) procedure and treatment plan you will undergo. During drug-induced sleep endoscopy (DISE), your measurement values, which we follow in every patient, will be recorded. An adhesive tape will be attached to your forehead area, especially to determine your sleep depth. It will be removed at the end of the procedure.
Detailed description
Volunteer patients between the ages of 18-65, both genders and ASA (American Society of Anesthesiology) I-II risk scores, who will undergo DISE with sedation after routine preoperative evaluation under elective conditions, will be included in the study.All patients participating in the study will be explained about the study and possible risks and informed consent will be obtained from the patients.
Exclusion criteria for the study: Patient unwillingness, being younger than 18 years of age, being older than 65 years of age, patients with ASA score greater than II, pregnant women, drug addicts, alcohol addicts, patients with congestive heart failure, need for intubation, patients receiving oxygen therapy at home, Patients with chronic analgesic use, patients known to be allergic to the anesthetic drugs used, patients with psychiatric disorders.
The patient age, weight, BMI, AHI index if any, existing chronic diseases, medications used, whether or not CPAP has been used at home for how many years, duration of the procedure, amount of medications used, whether the airway is intervened or not, hemodynamic(systolic arterial pressure, diastolic arterial pressure, average parameters (e.g. arterial pressure, heart rate, oxygen saturation) will be recorded throughout the procedure.
At the end of the procedure, the patient will be taken to the recovery unit and will be evaluated according to Aldrete criteria and if there is no problem, patient will be sent to the service.The patient\'s wake-up time, recovery time, and possible complications during recovery will be noted and treatment will be planned.
All patients entering the operating room will receive ASA monitoring (non-invasive arterial blood pressure, ECG, oxygen saturation) followed by 4-channel EEG monitoring and baseline values will be noted.After a 4lt/min nasal oxygen cannula is placed, 1 mg midazolam and 50 mcg fentanyl will be given to group I, and then propofol infusion will be started at a dose of 50-100 mcg/kg/min, following an initial dose of 1mg/kg.In group II, infusion will be started at a dose of 0.2-0.7 mcg/kg/h after a loading dose of 1 mg midazolam, 50 mcg fentanyl followed by 1 mcg/kg dexmetedomidine.Anesthesia depth dose adjustment will be made according to the 60-70 PSI value range in the 4-channel EEG. The time to reach the adequate processing level will be recorded.Patients who have reached the target depth of sedation but have hypertension will be given an additional 0.1 mg of glyceryl trinitrate.Decreases of 25% from baseline blood pressure will be considered hypotension and will be treated with fluid boluses and/or followed by IV ephedrine.In the event of apnea or desaturation, airway management techniques such as patient stimulation, increased oxygen supplementation, chin lift, chin thrust maneuver will be applied and noted.
If the pulse rate drops below 50 bpm, treatment with IV 0.5 mg atropine will be considered. While the patient is being sent to the ward, the patient will be asked whether he or she has had a dream, and if so, its content will be noted.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group created with dexmedetomidine sedation | – | –infusion will be started at a dose of 0.2-0.7 mcg/kg/h after a loading dose of 1 mg midazolam, 50 mcg fentanyl followed by 1 mcg/kg dexmetedomidine. |
| group created with propofol sedation | – | –After 1 mg midazolam and 50 mcg fentanyl are given, propofol infusion will be started at a dose of 50-100 mcg/kg/min, following an initial dose of 0,5 mg/kg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ASA I-II patients between the ages of 18-65 who will undergo sleep endoscopy under sedation in the operating room of Ankara City Hospital Ear Nose and Throat Clinic.
Key inclusion criteria (1 listed)
- Volunteer patients of both genders and ASA (American Society of Anesthesiology) I-II risk scores, between the ages of 18-65, who will undergo DISE with sedation.
Key exclusion criteria (1 listed)
- Patient unwillingness, being younger than 18 years of age, being older than 65 years of age, patients with ASA score greater than II, pregnant women, drug addicts, alcohol addicts, patients with congestive heart failure, need for intubation, patients receiving oxygen therapy at home, Patients with chronic analgesic use, patients known to be allergic to the anesthetic drugs used, patients with psychiatric disorders.
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
Determination of sedation range in 4-channel EEG
Time frame: from March 2024 to December 2024
Evaluation of sedation depth using 4-channel EEG in drug-induced sleep endoscopy (DISE)"
1 secondary outcome
Evaluating the effectiveness of different sedation techniques,Snoring situation in the shortest time and effectively,Intraoperative drug consumption,Hemodynamic changes
Time frame: from March 2024 to December 2024
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 Nov 2025.
- Individual participant dataSharing planned: No
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.
Ezgi e Erkılıç, doc doctor study director
Ankara City Hospital Bilkent
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 Seeing the Benefits of Using 4 Channel EEG During the DISE Procedure With Sedation, run by Ankara City Hospital Bilkent 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 1 inclusion and 1 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 Nov 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?
Determination of sedation range in 4-channel EEG (time frame: from March 2024 to December 2024). 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 Nov 2025.