Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
Healthy Volunteers
NCT06777589

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

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

China,Chongqing The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China, 400016

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Quantitative Consciousness Index Monitoring (qNOX) of Sedation During Endoscopy | DecenTrialz