A clinical trial sponsored by Başakşehir Çam & Sakura City Hospital will investigate neuro-mimic observational techniques to enhance anesthesia management and patient safety during general anesthesia.
In this article:
- What is the focus of this clinical trial?
- Why is understanding anesthesia depth important?
- What are the trial details and design?
- FAQ
- Conclusion
- Disclaimer
- Full announcement
What is the focus of this clinical trial?
The upcoming clinical trial aims to assess the use of neuro-mimic indicators to quantify and monitor the depth of anesthesia during general anesthetic procedures. The innovative observation protocol explores potential correlations between neurophysiological responses, such as eye movements, and anesthesia depth.
Current challenges in anesthesia include balancing patient unconsciousness with safety. Mismanagement may lead to risks such as intraoperative awareness, a distressing condition associated with psychological complications. This study highlights the potential role of neuro-mimic markers to address such critical needs.
Why is understanding anesthesia depth important?
Anesthesia depth significantly impacts patient safety and outcomes. Precise monitoring minimizes risks like intraoperative awareness, where a patient regains consciousness or feels sensations during surgery. This condition affects an estimated 0.1–0.2% of patients undergoing general anesthesia globally.
Neuro-mimic mechanisms such as eye movement responses may provide rapid, non-invasive insights into patient states. Identifying reliable biomarkers could advance the field by providing anesthesiologists with more accurate tools to tailor anesthesia delivery.
What are the trial details and design?
The trial, sponsored by Başakşehir Çam & Sakura City Hospital, is expected to begin recruitment soon. It is listed as “not yet recruiting” as of the October 2025 update and will utilize the Neuro-Mimic Observation Protocol for data collection.
The protocol will specifically examine eye movements under varied anesthetic conditions, aiming to validate their potential as indicators of brain activity and consciousness levels. While this is not a diagnostic device trial, the research aligns closely with regulatory priorities for understanding physiological markers in clinical settings.
The trial’s outcomes could inform future recommendations for anesthesia monitoring technology and methodologies. For more details, you can access the official listing on ClinicalTrials.gov.
FAQ
1. What is the Neuro-Mimic Observation Protocol?
The Neuro-Mimic Observation Protocol explores neurophysiological responses such as eye movements as potential markers for anesthesia depth. The aim is to improve monitoring methods in anesthetic care.
2. Who is conducting the study?
The trial is sponsored by Başakşehir Çam & Sakura City Hospital, a well-established medical institution with prior experience in clinical research.
3. How does this research impact regulatory science?
Should the trial validate neuro-mimic markers, these findings could contribute to regulatory discussions on advanced monitoring protocols and medical device innovations.
Conclusion
The emergence of neuro-mimic methodologies to monitor anesthesia depth reflects an innovative step forward in patient safety and anesthesia care. While the study has yet to commence recruitment, it could provide valuable insights into the potential of such indicators to revolutionize the practice.
Disclaimer
This article is intended for informational purposes only and does not serve as legal advice. Readers are encouraged to consult professional sources for specific regulatory or clinical guidance.
Full announcement
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07199049?term=medical+device