Brain‑wave and pain‑signal monitoring during anesthesia for ERCP to map opioid and sedative effects
Official title: Pharmacodynamic Effects of Propofol and Alfentanil on EEG During Endoscopic Retrograde Cholangiopancreatography (ERCP)
Run by China Medical University Hospital · NCT07211828 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | China Medical University Hospital Academic / other |
| Locations | 1 site (Miaoli) |
| Status | Recruiting |
| Started | October 10, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | June 16, 2028 |
| Registry record updated | March 27, 2026 |
| Trial ID | NCT07211828 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Temperature management during long abdominal surgeries
This study tests whether warming intravenous fluids to 39 °C, in addition to standard warm air warming, helps keep patients warmer during long abdominal operations compared with using room-temperature fluids.
-
Ketamine-Propofol vs Dexmedetomidine-Propofol Sedation for Pediatric Cardiac Catheterization
This study tests two sedative combinations to see which is safer and more effective for children 2–12 undergoing device closure of simple left-to-right heart shunts.
-
Quality of Recovery after opioid-free vs opioid-based general anesthesia in major urological surgery
This trial tests whether opioid-free anesthesia leads to a better recovery score, as measured by QoR-15, in adults undergoing major urological surgery compared to anesthesia with remifentanil.
-
Impact of Anesthesia on Inflammation and NETosis During HCC Ablation
This study tests whether a propofol–fentanyl anesthesia plan with lidocaine during radiofrequency ablation for hepatocellular carcinoma affects inflammation and NETosis in patients with small tumors.
-
EASIX and Post-Induction Hypotension in Frail Adults Undergoing Non-Cardiac Surgery
This study tests whether the EASIX score, calculated from routine labs, can predict post-induction low blood pressure in frail adults having elective non-cardiac surgery under general anesthesia.
-
Two anesthesia methods to keep the joint clear during shoulder arthroscopy
This trial tests whether inhaled sevoflurane vs. total intravenous anesthesia with propofol affects how well surgeons can see inside the shoulder during rotator cuff repair.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.