Brain‑wave and pain‑signal monitoring during anesthesia for ERCP to map opioid and sedative effects
Pharmacodynamic Effects of Propofol and Alfentanil on EEG During Endoscopic Retrograde Cholangiopancreatography (ERCP)
This trial will test whether continuous brain‑wave (EEG/PSI) and heart‑rate variability (ANI) monitoring during targeted infusions of opioids and sedatives can show how those drugs interact in people having ERCP under general anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | China Medical University Hospital Academic / other |
| Locations | 1 site (Miaoli) |
| Trial ID | NCT07211828 on ClinicalTrials.gov |
What this trial studies
Participants undergoing ERCP under general anesthesia will receive target‑controlled infusions (TCI) of opioids and sedatives with protocols comparing higher and lower alfentanil dosing combined with propofol while continuous EEG (PSI and raw EEG) and Analgesia Nociception Index (ANI) are recorded. The study will analyze how different dosing regimens influence PSI, raw EEG patterns, and HRV‑derived ANI to characterize pharmacodynamic interactions between opioids and sedatives. Data will be collected throughout the anesthesia period and correlated with infusion targets and clinical events to identify signal changes linked to sedation depth and nociception. Results aim to clarify how combined drug dosing affects common monitoring indices and support safer intraoperative dosing strategies.
Who should consider this trial
Good fit: Adults scheduled for ERCP who require general anesthesia and do not meet exclusion criteria (for example ASA class <4 and not members of vulnerable groups) are the intended participants.
Not a fit: Patients who are ASA class 4 or higher, prisoners, those with significant cognitive or physical disabilities, or HIV carriers were excluded and would not be eligible to participate or benefit from the protocol.
Why it matters
Potential benefit: If successful, findings could help clinicians tailor opioid and sedative dosing during procedures like ERCP to reduce the risk of under‑ or over‑sedation.
How similar studies have performed: PSI and ANI have been used together in prior anesthetic practice and research to guide sedation and analgesia, but applying simultaneous TCI infusion protocols with combined PSI/EEG and ANI recording to map drug interactions is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who under go ERCP who require general anesthesia Exclusion Criteria: * ASA\> or = 4 , vulnerable groups such as prisoners, patients with physical or mental disabilities and HIV carriers
Where this trial is running
Miaoli
- Wei Gong Memorial Hospital — Miaoli, Taiwan (Recruiting)
Study contacts
- Principal investigator: Chi Kwan Boris Fung, MD — Wei Gong Memorial Hospital
- Study coordinator: Chi Kwan Boris Fung, MD
- Email: 024666@tool.caaumed.org.tw
- Phone: 886-037-676811
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.