Clinical trial NCT06866886: EEG-Guided Sedation in ERCP Procedures
Official title: Evaluation of the Depth of Sedation in Patients Undergoing Endoscopic Retrograde Cholangio Pancreatography (ERCP) With 4-Channel Electroencephalography (EEG)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anesthesia
Sedation
Sedation Complication
Anesthesia, Intravenous
Monitoring of Depth of Anesthesia
Recovery From Anesthesia
Keywords: patient state index
EEG
ERCP
sedation
PSI
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Total Anesthetic Consumption
timeFrame: From anesthesia induction to the end of sedation during the ERCP procedure
measure: Recovery Time from Anesthesia
timeFrame: Assessed at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 minutes post-anesthesia discontinuation, up to 60 minutes.
measure: Sedation Depth Maintenance
timeFrame: 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:
measure: Hemodynamic Stability
timeFrame: Continuously monitored during the ERCP procedure and recorded at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes.
measure: Hemodynamic Stability
timeFrame: Continuously monitored during the ERCP procedure and recorded at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes.
measure: Hemodynamic Stability
timeFrame: Continuously monitored during the ERCP procedure and recorded at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes.
measure: Hemodynamic Stability
timeFrame: Continuously monitored during the ERCP procedure and recorded at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes.
measure: Hemodynamic Stability
timeFrame: Continuously monitored during the ERCP procedure and recorded at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes.
measure: Incidence of Respiratory and Cardiovascular Complications
timeFrame: During the ERCP procedure (intraoperative period)
measure: Intervention Rate Due to Sedation-Related Instability
timeFrame: During the ERCP procedure (intraoperative period)
measure: Time to Awakening from Anesthesia
timeFrame: Assessed at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 minutes post-anesthesia discontinuation, up to 60 minutes.
measure: Total Procedure Duration
timeFrame: From the start to the completion of the ERCP procedure
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Ayça Özcan
role: PRINCIPAL_INVESTIGATOR
References: