Quantitative Consciousness Index Monitoring (qNOX) of Sedation During Endoscopy (NCT06777589) | Clinical Trial Compass
RecruitingNot Applicable
Quantitative Consciousness Index Monitoring (qNOX) of Sedation During Endoscopy
China900 participantsStarted 2025-06-01
Plain-language summary
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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Age between 18 and 60 years old;
✓. ASA-PS (American Society of Anesthesiologists Physical Status) classification of I to II;
✓. Body Mass Index (BMI): 18 to 28 kg/m²;
✓. Patients undergoing diagnostic and therapeutic procedures under sedation for lower gastrointestinal endoscopy;
✓. Clear understanding and voluntary participation in this study, with informed consent signed.
Exclusion criteria
✕. Patients requiring complex endoscopic techniques for diagnosis and treatment;
✕. Patients who have participated in other clinical trials in the past three months;
✕. Pregnant and lactating patients;
✕. Patients with allergies to sedatives/anesthetics and other severe anesthesia risks;
✕. Patients with preoperative chronic pain or a history of substance abuse;
What they're measuring
1
The value of qNOX
Timeframe: Start of the procedure，when the gastroscope passes through the pharynx or the colonoscope passes through the anus.
✕. Patients with severe neurological diseases such as stroke, hemiplegia, convulsions, epilepsy, etc.;
✕. Patients with known difficult airways such as limited mouth opening, restricted neck and jaw movement, rheumatoid spondylitis, temporomandibular joint arthritis, etc.;
✕. Patients with potentially life-threatening circulatory and respiratory diseases that are not adequately controlled, such as uncontrolled severe hypertension, severe arrhythmias, unstable angina pectoris, acute respiratory infections, asthma exacerbations, etc.;