AnesthesiaERCP-EEGNCT06866886
EEG-Guided Sedation in ERCP Procedures
An observational study of Anesthesia and Sedation, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Patients undergoing ERCP have a wide range from patients with poor general condition and septicaemia findings to outpatients who come as day patients without any other additional disease. Rapid deterioration in vital signs may be encountered especially during sedation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia, Sedation, Sedation Complication
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2025to 21 Aug 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Volunteer patients aged 18-65 years, of both sexes, with ASA I-II-III risk score, undergoing elective ERCP procedure
Who may be able to join
- ASA I-II-III risk score
- Volunteer patients
- Patients aged 18-65 years of both sexes undergoing elective ERCP procedure
Who cannot join
- Patient reluctance
- Being under 18 years of age
- Being over 65 years of age
- ASA risk score of 4 and above 4
- Pregnant women
- Those with neurological conditions
- Patients with difficult airways
- Obesity (BMI>30)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Depth of Sedation in Patients Undergoing Endoscopic Retrograde Cholangio Pancreatography (ERCP) With 4-Channel Electroencephalography (EEG)
Patients undergoing ERCP have a wide range from patients with poor general condition and septicaemia findings to outpatients who come as day patients without any other additional disease. Rapid deterioration in vital signs may be encountered especially during sedation. In this patient group, it is important to titrate the anaesthetic agent at appropriate doses and to adjust the dose according to the patient.
The aim of the study is to optimise the level of sedation using 4-channel electroencephalography (EEG) in these patients, thus providing balanced anaesthesia and rapid recovery in this already challenging patient group.
Read the detailed description
Volunteers in the ASA (American Society of Anaesthesiology) I-II-III risk group, aged between 18-65 years, of both sexes, who will undergo ERCP procedure under elective conditions with routine preoperative examination will be included. Before the procedure, the study and all possible risks will be explained to all patients and informed consent will be obtained. Patient's age, weight, ASA value, chronic diseases will be recorded before the procedure. Patients will be divided into two groups. All patients will be routinely monitorised for ECG, non-invasive arterial blood pressure, SpO2, respiratory rate, end-tidal CO2 measurement. These values will be noted at five minute intervals. All patients will receive oxygen at 2 L/min through a nasal cannula. In the case group, in addition to routine monitoring, PSI value measurement will be performed by applying PSI electrodes after wiping the forehead with an alcohol sponge and drying it. All patients will be induced with Propofol at a dose of 1 mg/kg and maintained by infusion at a dose of 50-150 mcg/kg/min according to the patient's need. All procedures will be performed by a single gastroenterologist. In addition, an assessment will be made every five minutes according to the Ramsey Sedation Scale (RSS). An RSS of 2-3 is considered as light sedation and 4 as deep sedation. The duration of the procedure, duration of anaesthesia, total amount of anaesthetic given, time to awakening from anaesthesia (time until Ramsey Score: 1), recovery time (time until Aldrete Score: 10) will be noted.
- Conditions
- Anesthesia, Sedation, Sedation Complication, Anesthesia, Intravenous, Monitoring of Depth of Anesthesia, Recovery From Anesthesia
- Keywords
- patient state index, EEG, ERCP, sedation, PSI
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 |
|---|---|---|
| CASE GROUP | All patients will undergo routine monitoring, including ECG, blood pressure, SpO₂, respiratory rate, and end-tidal CO₂ measurements. 42 patients receiving EEG-based Patient State Index (PSI) monitoring to optimize sedation depth. PSI electrodes will be applied, and sedation levels will be adjusted accordingly. Oxygen will be administered at 2 L/min via a nasal cannula. Propofol will be used for sedation, with doses adjusted based on patient needs. Any complications that arise and the interventions performed will also be recorded. The procedure duration, total anesthesia duration, total anesthetic dosage, time to awakening from anesthesia (Ramsey Score: 1), and full recovery time (Aldrete Score: 10) will be recorded. | |
| CONTROL GROUP | All patients will undergo routine monitoring, including ECG, blood pressure, SpO₂, respiratory rate, and end-tidal CO₂ measurements. 42 patients receiving standard clinical sedation monitoring without EEG guidance. Sedation levels will be assessed using the Ramsey Sedation Scale (RSS). Propofol will be used for sedation, with doses adjusted based on patient needs. Oxygen will be administered at 2 L/min via a nasal cannula. Additionally, sedation levels will be evaluated every five minutes using the Ramsey Sedation Scale (RSS). An RSS score of 2-3 will be classified as light sedation, while a score of 4 will indicate deep sedation. Any complications that arise and the interventions performed will also be recorded. The procedure duration, total anesthesia duration, total anesthetic dosage, time to awakening from anesthesia (Ramsey Score: 1), and full recovery time (Aldrete Score: 10) will be recorded. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Anesthetic Consumption
The total amount of propofol (mg/kg) administered during the ERCP procedure
Measured: From anesthesia induction to the end of sedation during the ERCP procedure
Recovery Time from Anesthesia
The time required for the patient to regain consciousness after anesthesia, defined as the time to reach Aldrete Score of 10
Measured: Assessed at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 minutes post-anesthesia discontinuation, up to 60 minutes.
Sedation Depth Maintenance
The ability to maintain an optimal sedation level, defined as a Patient State Index (PSI) value around 50, throughout the ERCP procedure.
Measurement Scale:
Scale Used: Patient State Index (PSI) - Masimo SedLine Brain Function Monitor Score Range: 0 to 100
Interpretation:
0-12: Burst suppression (deep anesthesia) 25-50: Optimal sedation for general anesthesia >50: Light sedation or wakefulness Higher scores indicate lighter sedation, while lower scores indicate deeper sedation.
Measured: Sedation depth will be continuously monitored during the procedure and recorded at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes (PSI Score).
Secondary outcomes (9)
Hemodynamic Stability
Non-Invasive Arterial Blood Pressure (mmHg), including systolic, diastolic, and mean arterial pressure, measured using an automated non-invasive blood pressure monitor to compare intraoperative hemodynamic stability between the EEG-guided sedation group and the standard sedation group.
Measured: Continuously monitored during the ERCP procedure and recorded at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes.
Hemodynamic Stability
Heart Rate (beats per minute), measured using standard ECG monitoring to compare intraoperative heart rate stability between the EEG-guided sedation group and the standard sedation group.
Measured: Continuously monitored during the ERCP procedure and recorded at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes.
Hemodynamic Stability
Oxygen Saturation (SpO₂, %) measured using pulse oximetry to assess intraoperative oxygenation levels in patients undergoing EEG-guided sedation versus standard sedation during the ERCP procedure.
Measured: Continuously monitored during the ERCP procedure and recorded at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes.
Hemodynamic Stability
Respiratory Rate (breaths per minute) measured using continuous respiratory monitoring to assess intraoperative respiratory stability in patients undergoing EEG-guided sedation versus standard sedation during the ERCP procedure.
Measured: Continuously monitored during the ERCP procedure and recorded at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes.
Hemodynamic Stability
End-Tidal CO₂ (mmHg) measured using capnography to assess intraoperative ventilation status and respiratory function in patients undergoing EEG-guided sedation versus standard sedation during the ERCP procedure.
Measured: Continuously monitored during the ERCP procedure and recorded at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes.
Incidence of Respiratory and Cardiovascular Complications
The frequency of complications such as hypoxia, apnea, bradycardia, and hypotension
Measured: During the ERCP procedure (intraoperative period)
Intervention Rate Due to Sedation-Related Instability
The need for additional interventions such as airway support, fluid therapy, vasopressors, or increased oxygen administration due to sedation-related complications
Measured: During the ERCP procedure (intraoperative period)
Time to Awakening from Anesthesia
The time taken for the patient to regain consciousness, defined as the time to reach Ramsey Sedation Score (RSS) of 1.
Scale Used: Ramsey Sedation Scale (RSS) Score Range: 1 to 6
Interpretation:
1: Patient is awake, anxious, and agitated 2-3: Light sedation (responsive to verbal commands) 4: Deep sedation (responsive to light stimuli) 5-6: Unresponsive to stimuli (very deep sedation) Higher scores indicate deeper sedation, while lower scores indicate increased wakefulness.
Measured: Assessed at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 minutes post-anesthesia discontinuation, up to 60 minutes.
Total Procedure Duration
The overall time taken to complete the ERCP procedure
Measured: From the start to the completion of the ERCP procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start10 Mar 2025
- Primary completion21 Jul 2025
- Study completion21 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayça Özcan, Ankara City Hospital Bilkent
- Investigators
- Ayça Özcan, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866886
- Sponsor's protocol ID
- EthicsApproval: E2-24-7125
- Acronym
- ERCP-EEG
- Status last verified
- Mar 2025
- First submitted
- 24 Feb 2025
- Last updated
- 10 Dec 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 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Depth of Sedation in Patients Undergoing Endoscopic Retrograde Cholangio Pancreatography (ERCP) With 4-Channel Electroencephalography (EEG)
- ClinicalTrials.gov ID
- NCT06866886
- Acronym / sponsor ID
- ERCP-EEG / EthicsApproval: E2-24-7125
- Conditions
- Anesthesia, Sedation, Sedation Complication, Anesthesia, Intravenous, Monitoring of Depth of Anesthesia, Recovery From Anesthesia
- Keywords
- patient state index, EEG, ERCP, sedation, PSI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 21 Jul 2025 (actual)
- Study completion
- 21 Aug 2025 (actual)
- First posted
- 10 Mar 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.
Patients undergoing ERCP have a wide range from patients with poor general condition and septicaemia findings to outpatients who come as day patients without any other additional disease. Rapid deterioration in vital signs may be encountered especially during sedation. In this patient group, it is important to titrate the anaesthetic agent at appropriate doses and to adjust the dose according to the patient.
The aim of the study is to optimise the level of sedation using 4-channel electroencephalography (EEG) in these patients, thus providing balanced anaesthesia and rapid recovery in this already challenging patient group.
Detailed description
Volunteers in the ASA (American Society of Anaesthesiology) I-II-III risk group, aged between 18-65 years, of both sexes, who will undergo ERCP procedure under elective conditions with routine preoperative examination will be included. Before the procedure, the study and all possible risks will be explained to all patients and informed consent will be obtained. Patient's age, weight, ASA value, chronic diseases will be recorded before the procedure. Patients will be divided into two groups. All patients will be routinely monitorised for ECG, non-invasive arterial blood pressure, SpO2, respiratory rate, end-tidal CO2 measurement. These values will be noted at five minute intervals. All patients will receive oxygen at 2 L/min through a nasal cannula. In the case group, in addition to routine monitoring, PSI value measurement will be performed by applying PSI electrodes after wiping the forehead with an alcohol sponge and drying it. All patients will be induced with Propofol at a dose of 1 mg/kg and maintained by infusion at a dose of 50-150 mcg/kg/min according to the patient's need. All procedures will be performed by a single gastroenterologist. In addition, an assessment will be made every five minutes according to the Ramsey Sedation Scale (RSS). An RSS of 2-3 is considered as light sedation and 4 as deep sedation. The duration of the procedure, duration of anaesthesia, total amount of anaesthetic given, time to awakening from anaesthesia (time until Ramsey Score: 1), recovery time (time until Aldrete Score: 10) will be noted.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CASE GROUP | – | –All patients will undergo routine monitoring, including ECG, blood pressure, SpO₂, respiratory rate, and end-tidal CO₂ measurements. 42 patients receiving EEG-based Patient State Index (PSI) monitoring to optimize sedation depth. PSI electrodes will be applied, and sedation levels will be adjusted accordingly. Oxygen will be administered at 2 L/min via a nasal cannula. Propofol will be used for sedation, with doses adjusted based on patient needs. Any complications that arise and the interventions performed will also be recorded. The procedure duration, total anesthesia duration, total anesthetic dosage, time to awakening from anesthesia (Ramsey Score: 1), and full recovery time (Aldrete Score: 10) will be recorded. |
| CONTROL GROUP | – | –All patients will undergo routine monitoring, including ECG, blood pressure, SpO₂, respiratory rate, and end-tidal CO₂ measurements. 42 patients receiving standard clinical sedation monitoring without EEG guidance. Sedation levels will be assessed using the Ramsey Sedation Scale (RSS). Propofol will be used for sedation, with doses adjusted based on patient needs. Oxygen will be administered at 2 L/min via a nasal cannula. Additionally, sedation levels will be evaluated every five minutes using the Ramsey Sedation Scale (RSS). An RSS score of 2-3 will be classified as light sedation, while a score of 4 will indicate deep sedation. Any complications that arise and the interventions performed will also be recorded. The procedure duration, total anesthesia duration, total anesthetic dosage, time to awakening from anesthesia (Ramsey Score: 1), and full recovery time (Aldrete Score: 10) will be recorded. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteer patients aged 18-65 years, of both sexes, with ASA I-II-III risk score, undergoing elective ERCP procedure
Key inclusion criteria (3 listed)
- ASA I-II-III risk score
- Volunteer patients
- Patients aged 18-65 years of both sexes undergoing elective ERCP procedure
Key exclusion criteria (8 listed)
- Patient reluctance
- Being under 18 years of age
- Being over 65 years of age
- ASA risk score of 4 and above 4
- Pregnant women
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
Total Anesthetic Consumption
Time frame: From anesthesia induction to the end of sedation during the ERCP procedure
The total amount of propofol (mg/kg) administered during the ERCP procedure
Recovery Time from Anesthesia
Time frame: Assessed at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 minutes post-anesthesia discontinuation, up to 60 minutes.
The time required for the patient to regain consciousness after anesthesia, defined as the time to reach Aldrete Score of 10
Sedation Depth Maintenance
Time frame: Sedation depth will be continuously monitored during the procedure and recorded at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes (PSI Score).
The ability to maintain an optimal sedation level, defined as a Patient State Index (PSI) value around 50, throughout the ERCP procedure. Measurement Scale: Scale Used: Patient State Index (PSI) - Masimo SedLine Brain Function Monitor Score Range: 0 to 100 Interpretation: 0-12: Burst suppression (deep anesthesia) 25-50: Optimal sedation for general anesthesia >50: Light sedation or wakefulness Higher scores indicate lighter sedation, while lower scores indicate deeper sedation.
9 secondary outcomes
Hemodynamic Stability
Time frame: Continuously monitored during the ERCP procedure and recorded at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes.
Hemodynamic Stability
Time frame: Continuously monitored during the ERCP procedure and recorded at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes.
Hemodynamic Stability
Time frame: Continuously monitored during the ERCP procedure and recorded at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes.
Hemodynamic Stability
Time frame: Continuously monitored during the ERCP procedure and recorded at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes.
Hemodynamic Stability
Time frame: Continuously monitored during the ERCP procedure and recorded at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes.
Incidence of Respiratory and Cardiovascular Complications
Time frame: During the ERCP procedure (intraoperative period)
Intervention Rate Due to Sedation-Related Instability
Time frame: During the ERCP procedure (intraoperative period)
Time to Awakening from Anesthesia
Time frame: Assessed at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 minutes post-anesthesia discontinuation, up to 60 minutes.
Total Procedure Duration
Time frame: From the start to the completion of the ERCP procedure
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 10 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Ayça Özcan principal investigator
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 Anesthesia and 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 3 inclusion and 8 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 10 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?
Total Anesthetic Consumption (time frame: From anesthesia induction to the end of sedation during the ERCP procedure). The study lists 3 primary outcomes in all. 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 10 Dec 2025; AzTrials last refreshed its copy on 27 Oct 2026.