Actively Recruiting
Pharmacodynamic Effects of Propofol and Alfentanil on EEG During Endoscopic Retrograde Cholangiopancreatography (ERCP)
Led by Chi Kwan Fung · Updated on 2026-03-27
20
Participants Needed
1
Research Sites
76 weeks
Total Duration
On this page
Sponsors
C
Chi Kwan Fung
Lead Sponsor
N
National Yang Ming Chiao Tung University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to investigate the effects of opioids and sedatives on brain activity and pain monitoring during anesthesia, focusing on patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). The study measures brain waves and pain responses using the Patient State Index (PSI), raw electroencephalogram (EEG) data, and the Analgesia Nociception Index (ANI) to better understand the interaction of these drugs. This interaction is important for preventing drug overdose and improving anesthesia care. Participants receive continuous administration of opioids and sedative drugs through target-controlled infusion (TCI) during the procedure. Two treatment approaches are compared: one where the dose of alfentanil is increased first before adjusting propofol, aiming for a higher alfentanil dose, and another where propofol is increased first before alfentanil, aiming for a lower alfentanil dose. Doses are adjusted to reach specific PSI target ranges during anesthesia. Throughout the study, brain wave patterns, PSI, ANI, and vital signs like blood pressure, heart rate, and oxygen saturation are monitored before and during the procedure. Researchers analyze EEG alpha, beta, and delta power ratios and other cardiac output measures to assess the pharmacodynamic effects. The study involves randomized assignment to treatment groups with double masking and continues until the end of the procedure, with safety and effectiveness monitored by various measurements.
CONDITIONS
Brief Title
EEG and Pain Monitor Data Under Anesthesia to Study Pharmacodynamic Effects of Opioids and Sedatives
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing ERCP who require general anesthesia
You will not qualify if you...
- ASA classification of 4 or higher
- Vulnerable groups such as prisoners
- Patients with physical or mental disabilities
- HIV carriers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of the ERCP procedure and anesthesia
Participants receive sedation with opioids and sedative drugs administered via target-controlled infusion during the ERCP procedure. The dose of alfentanil and propofol is adjusted to achieve a target Patient State Index (PSI) between 25-50. Participants are monitored continuously for brain wave patterns and pain/stress response during anesthesia.
1 procedure visit (in-person)
Trial Site Locations
Total: 1 location
1
Wei Gong Memorial Hospital
Miaoli, Taiwan
Actively Recruiting
Research Team
C
Chi Kwan Boris Fung, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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