Optimizing sedation during ERCP procedures using EEG monitoring
Evaluation of the Depth of Sedation in Patients Undergoing Endoscopic Retrograde Cholangio Pancreatography (ERCP) With 4-Channel Electroencephalography (EEG)
This study is testing if using EEG to monitor sedation can help patients aged 18-65 recover faster and feel more comfortable during ERCP procedures compared to traditional methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ankara City Hospital Bilkent Academic / other |
| Locations | 1 site (Ankara) |
| Trial ID | NCT06866886 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enhance sedation management for patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) by utilizing 4-channel electroencephalography (EEG) to monitor the depth of sedation. Patients aged 18-65 with ASA risk scores of I-III will be included, and their sedation levels will be adjusted based on EEG readings and standard monitoring techniques. The study will compare traditional sedation methods with EEG-guided approaches to ensure balanced anesthesia and quicker recovery times. Data on vital signs and sedation levels will be collected throughout the procedure to assess the effectiveness of the EEG monitoring.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18-65 with ASA risk scores of I-III who are scheduled for elective ERCP procedures.
Not a fit: Patients who may not benefit include those under 18 or over 65, those with ASA risk scores of IV or higher, pregnant women, individuals with neurological conditions, and patients with difficult airways or obesity.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more effective sedation practices during ERCP procedures, improving patient outcomes.
How similar studies have performed: While EEG monitoring in sedation is a growing field, this specific application in ERCP procedures is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Ankara
- Ankara Bilkent City Hospital — Ankara, Turkey (Recruiting)
Study contacts
- Principal investigator: Ayça Özcan — Ankara City Hospital Bilkent
- Study coordinator: Hasret G Kargın
- Email: hasretgulfem@gmail.com
- Phone: +905372068489
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.