EEG-Guided Sedation in ERCP Procedures

NCT06866886 | Completed

• 1 other identifier: EthicsApproval: E2-24-7125
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Monitoring of Depth of Anesthesia; Recovery From Anesthesia; Anesthesia; Sedation; Sedation Complication; Anesthesia, Intravenous

Keywords

patient state index; EEG; ERCP; sedation; PSI

Outcome Measures

Primary Outcomes (3)

• Total Anesthetic Consumption

  The total amount of propofol (mg/kg) administered during the ERCP procedure

  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

  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.

  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

  Continuously monitored during the ERCP procedure and recorded at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes.

• Hemodynamic Stability

  Continuously monitored during the ERCP procedure and recorded at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes.

• Hemodynamic Stability

  Continuously monitored during the ERCP procedure and recorded at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes.

• Hemodynamic Stability

  Continuously monitored during the ERCP procedure and recorded at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes.

• Hemodynamic Stability

  Continuously monitored during the ERCP procedure and recorded at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Volunteer patients aged 18-65 years, of both sexes, with ASA I-II-III risk score, undergoing elective ERCP procedure

You may qualify if:

• ASA I-II-III risk score
• Volunteer patients
• Patients aged 18-65 years of both sexes undergoing elective ERCP procedure

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Location

Study Officials

• Ayça Özcan

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 10, 2025
• Study Start: March 10, 2025
• Primary Completion: July 21, 2025
• Study Completion: August 21, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)