A clinical trial scheduled to begin in the near future aims to explore the pharmacodynamic effects of opioid and sedative combinations using EEG and pain monitor data during anesthesia. Supported by Chi Kwan Fung, National Yang Ming Chiao Tung University, and WeiGong Memorial Hospital, this study addresses sedation, analgesia, and endoscopic retrograde cholangiopancreatography under general anesthesia. Researchers plan to assess two specific drug dosages in depth.
What is the study’s focus?
The targeted trial focuses on exploring how different doses of alfentanil alone and in combination with propofol influence EEG and pain monitoring results during anesthesia. This investigation intends to improve understanding of pharmacodynamic responses in patients undergoing sedation and analgesia during invasive procedures, such as endoscopic retrograde cholangiopancreatography.
EEG monitoring can provide critical insights into brain activity during states of induced sedation, while pain monitoring may help quantify analgesic effectiveness. By combining these tools, researchers aim to improve dosage precision and patient safety.
How will the study be conducted?
Drug dosages and interventions
The trial will compare two intervention groups: one using a high dose of alfentanil and the other combining a low dose of alfentanil with propofol. EEG and pain data will be recorded and analyzed to measure responses.
This approach allows researchers to evaluate differences in patient sedation levels and pain management effectiveness, providing insights that may refine clinical guidelines.
Clinical context
General anesthesia for minimally invasive procedures often requires a balanced combination of sedatives and opioids to achieve optimal results. This trial may highlight ways to reduce adverse effects, such as excessive sedation or insufficient pain control, through optimized drug dosing.
What are the regulatory implications?
As this study progresses, findings will likely contribute to broader medical device regulatory developments. Data from EEG monitoring devices may receive closer attention, aligning with requirements outlined in the Medical Device Regulation (MDR) Annex XIV regarding performance evaluation and clinical evidence for active monitoring technologies.
Additionally, the trial outcomes may influence recommendations for anesthetic drug use by improving patient safety protocols and standardizing administration adjustments based on measured pharmacodynamics.
Frequently Asked Questions
1. When will the study recruit participants?
The study is listed as “not yet recruiting” as of the date of this announcement.
2. What conditions are being addressed?
The trial focuses on sedation, analgesia, and general anesthesia during endoscopic retrograde cholangiopancreatography procedures.
3. What organizations are involved?
The sponsoring organizations include Chi Kwan Fung, National Yang Ming Chiao Tung University, and WeiGong Memorial Hospital.
Summary and Implications
This upcoming study promises to advance our understanding of opioid and sedative pharmacodynamics during anesthesia by pairing EEG and pain monitor data for clinical evaluation. The results could lead to improved patient outcomes and regulatory refinements for medical devices and anesthetic protocols. Clinical, quality, and regulatory teams should monitor these developments closely.
Disclaimer
This article is intended for informational purposes only and does not constitute legal, medical, or financial advice. For specific advice or guidance, consult a qualified professional.
Announcement and Source Link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07211828?term=medical+device