Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07211828

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing ERCP who require general anesthesia
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Loading map...

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

Similar Trials

Asleep Fiberoptic vs Direct Laryngoscopy Effect on Hemodynam...

Analgesics, Opioid

Actively Recruiting

1 location

Evaluation of Moderate Hypercapnia During General Anesthesia...

Ischemic Stroke, Acute

Actively Recruiting

1 location

Evaluation of the ResQ Device Comparing Fluid Responsiveness...

Fluid Responsiveness Predictability

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here