Actively Recruiting
Quantitative Consciousness Index Monitoring (qNOX) of Sedation During Endoscopy
Led by Min Su · Updated on 2025-06-02
900
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Nociception is the encoding and processing of noxious stimulation and is considered an objective indicator for monitoring pain. Currently, a new clinically-applied medical-engineering integrated monitoring device for noxious stimulation response has emerged. Its fundamental principle is based on the monitoring of electroencephalographic (EEG) activity, incorporating two monitoring parameters: the quantitative consciousness (qCON) index and the quantitative nociceptive (qNOX) index. This device enables more precise monitoring of anesthesia depth, quantification of patients' anesthesia analgesia and stress levels, and reliable monitoring of responses to noxious stimulation. During tracheal intubation for general anesthesia, when the qCON value falls within the range of 40 to 60 and the qNOX value is between 30 and 50, it indicates that the patient is in an appropriate state of sedation and analgesia. However, there is currently no universally acknowledged standard for the optimal qNOX reference range during conscious sedation endoscopy. Therefore, this study utilizes the noxious stimulation response index (qNOX) to monitor noxious stimulation during the procedure, aiming to identify the best timing for inserting the endoscope during conscious sedation endoscopy and explore the appropriate range of qNOX for this purpose.
CONDITIONS
Official Title
Quantitative Consciousness Index Monitoring (qNOX) of Sedation During Endoscopy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 60 years old
- ASA-PS physical status classification of I to II
- Body Mass Index between 18 and 28 kg/m8
- Undergoing diagnostic or therapeutic sedation for lower gastrointestinal endoscopy
- Understands the study and has signed informed consent
You will not qualify if you...
- Need for complex endoscopic techniques for diagnosis or treatment
- Participation in other clinical trials within the past three months
- Pregnancy or lactation
- Allergies to sedatives, anesthetics, or severe anesthesia risks
- Chronic pain before surgery or history of substance abuse
- Severe neurological diseases such as stroke, hemiplegia, convulsions, or epilepsy
- Known difficult airways including limited mouth opening or restricted neck/jaw movement
- Uncontrolled serious circulatory or respiratory diseases like severe hypertension or unstable angina
- Liver dysfunction (Child-Pugh Class C or higher), acute upper gastrointestinal bleeding with shock, severe anemia, or gastrointestinal obstruction with gastric retention
AI-Screening
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Trial Site Locations
Total: 1 location
1
China,Chongqing The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400016
Actively Recruiting
Research Team
Q
Qin Liu
CONTACT
S
Su Min
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
4
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