Anesthesia, Anesthesia, Intravenous, Monitoring of Depth of Anesthesia, Recovery From Anesthesia, Sedation, Sedation Complication
Conditions
Keywords
patient state index, EEG, ERCP, sedation, PSI
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.
Interventions
None listed
Sponsors
Ankara City Hospital Bilkent
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Hemodynamic Stability | 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. |
| Total Procedure Duration | From the start to the completion of the ERCP procedure | The overall time taken to complete 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 |
Countries
Turkey (Türkiye)
Outcome results
None listed