Actively Recruiting
Exploration of the Range of the Quantitative Nociception Index (qNOX) During Gastrointestinal Endoscopy Under Intravenous Sedation: a Multicenter Clinical Study
Led by Min Su · Updated on 2025-06-02
900
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of a new medical device that monitors brain activity to better understand pain responses during sedation-assisted gastrointestinal endoscopy. The study aims to find the best timing for inserting the endoscope during conscious sedation by assessing the quantitative nociception index (qNOX), which helps measure pain responses. This study also explores the ideal qNOX range for safe and effective sedation during endoscopic procedures. Participants will undergo gastroscopy or colonoscopy with sedation using either propofol alone or propofol combined with a low dose of sufentanil. The Bispectral Index Monitor (Apollo-9000A) will track the quantitative consciousness index (qCON) and qNOX throughout the procedures. The propofol induction dose ranges from 1.5 to 2.5 mg/kg, administered by syringe pump, with ongoing infusion during the examination. Different groups receive varying sedation protocols to compare outcomes. During the study, researchers will record qCON, qNOX, blood pressure, heart rate, oxygen saturation, and sedation scores at multiple time points from the start to the end of the procedure. Adverse events during and after endoscopy will also be monitored up to 24 hours post-procedure. The primary outcome is the qNOX value at the start of the procedure when the endoscope passes specific anatomical points. Overall, participant involvement lasts until after the procedure with close monitoring of sedation and response measures.
CONDITIONS
Brief 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 classification of I to II
- Body Mass Index (BMI) between 18 and 28 kg/m²
- Patients undergoing diagnostic or therapeutic procedures under sedation for lower gastrointestinal endoscopy
- Clear understanding and voluntary participation with signed informed consent
You will not qualify if you...
- Patients requiring complex endoscopic techniques for diagnosis or treatment
- Participation in other clinical trials within the past three months
- Pregnant or lactating patients
- Allergies to sedatives or anesthetics or other severe anesthesia risks
- Preoperative chronic pain or history of substance abuse
- Severe neurological diseases such as stroke, hemiplegia, convulsions, or epilepsy
- Known difficult airway conditions like limited mouth opening or restricted neck and jaw movement
- Uncontrolled severe circulatory or respiratory diseases such as severe hypertension, arrhythmias, unstable angina, respiratory infections, or asthma exacerbations
- Liver dysfunction classified as 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 hour
Participants undergo gastroscopy or colonoscopy procedures under intravenous sedation with monitoring of anesthesia depth using the Bispectral Index Monitor (Apollo-9000A) to track their quantitative consciousness and nociception indices during the examination.
1 visit (in-person) during the endoscopy procedure
Duration - 24 hours
Participants are observed for adverse events and complications for 24 hours after the endoscopy procedure.
1 follow-up contact within 24 hours after procedure
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
S
Su Min
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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