EEG-Guided Sedation in ERCP Procedures

Last updated: March 19, 2025
Sponsor: Ankara City Hospital Bilkent
Overall Status: Active - Recruiting

Phase

N/A

Condition

Anesthesia

Treatment

N/A

Clinical Study ID

NCT06866886
EthicsApproval: E2-24-7125
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ASA I-II-III risk score

  • Volunteer patients

  • Patients aged 18-65 years of both sexes undergoing elective ERCP procedure

Exclusion

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

Total Participants: 84
Study Start date:
March 10, 2025
Estimated Completion Date:
August 21, 2025

Study 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.

Connect with a study center

  • Ankara Bilkent City Hospital

    Ankara,
    Turkey

    Active - Recruiting

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