EEG-Guided Sedation in ERCP Procedures (ERCP-EEG)

Ankara City Hospital

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT06866886

EthicsApproval: E2-24-7125

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

84 participants in 2 patient groups

CASE GROUP

Description:

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

Description:

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.