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Completed

NCT Number: NCT06866886

EEG-Guided Sedation in ERCP Procedures

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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.

Secondary outcomes

  1. 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.

    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.

  2. 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.

    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.

  3. 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.

    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.

  4. 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.

    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.

  5. 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.

    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.

  6. Incidence of Respiratory and Cardiovascular Complications

    Time frame: During the ERCP procedure (intraoperative period)

    The frequency of complications such as hypoxia, apnea, bradycardia, and hypotension

  7. Intervention Rate Due to Sedation-Related Instability

    Time frame: During the ERCP procedure (intraoperative period)

    The need for additional interventions such as airway support, fluid therapy, vasopressors, or increased oxygen administration due to sedation-related complications

  8. 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.

    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.

  9. Total Procedure Duration

    Time frame: From the start to the completion of the ERCP procedure

    The overall time taken to complete the ERCP procedure

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Evaluation of the Depth of Sedation in Patients Undergoing Endoscopic Retrograde Cholangio Pancreatography (ERCP) With 4-Channel Electroencephalography (EEG)

Acronym: ERCP-EEG

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2025
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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