EEG-Guided Sedation in ERCP Procedures

Recruiting

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

• Registration Number: NCT06866886
• Lead Sponsor: Ankara City Hospital Bilkent

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.

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 Timeline

• Study First Submitted: 2025-02-24
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-06
• Study Start: 2025-03-10
• Study First Posted: 2025-03-10
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-20
• Primary Completion: 2025-07-21
• Study Completion: 2025-08-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total Anesthetic Consumption	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	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	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 Outcome Measures

Name	Time	Method
Hemodynamic Stability	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.
Incidence of Respiratory and Cardiovascular Complications	During the ERCP procedure (intraoperative period)	The frequency of complications such as hypoxia, apnea, bradycardia, and hypotension
Intervention Rate Due to Sedation-Related Instability	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
Time to Awakening from Anesthesia	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.
Total Procedure Duration	From the start to the completion of the ERCP procedure	The overall time taken to complete the ERCP procedure

Trial Locations

Locations (1)

Ankara Bilkent City Hospital; 🇹🇷 Ankara, Turkey