Quantitative Consciousness Index Monitoring (qNOX) of Sedation During Endoscopy

ConditionNociception
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorMin Su

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Monitoring of anesthesia depth

Treatment groups

900 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Min Su

Lead sponsor

First Affiliated Hospital of Chongqing Medical University

Sponsor institution