qCON and qNOX-Guided Sedation Monitoring During Gastrointestinal Endoscopy: A Prospective Observational Preliminary Study.
Qin Liu, Dayuan Wei, Xiaoge Han...
https://pubmed.ncbi.nlm.nih.gov/42016204Actively Recruiting
Age: 18Years - 60Years
All Genders
ID06604156
The Effect of the Nociception Index (qNOX) in Painless Gastrointestinal Endoscopy :a Clinical Study
Led by Min Su · Updated on 2025-03-06
220
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how to best monitor sedation and pain response during painless gastrointestinal endoscopy using a new medical device that measures brain activity. This device records two indices, the quantitative consciousness (qCON) and quantitative nociceptive (qNOX), which may reflect sedation depth and pain signals. The study aims to combine these measurements with visual and physiological monitoring to find the optimal sedation level during gastroscopy and colonoscopy procedures. This single-center, prospective observational study involves 220 patients, evenly split between gastroscopy and colonoscopy groups. Patients receive anesthesia induction with propofol and sufentanil, monitored by an EEG bispectral index device (Apollo-9000A) to track qCON and qNOX values. The sedation is adjusted to keep patients at a low alertness level with no body movements during the procedures. Clinical signs like cough reflex and vital signs are also recorded. Participants will be observed throughout the procedure with measurements of qCON, qNOX, blood pressure, heart rate, oxygen saturation, and sedation scores. Adverse events during and up to 24 hours after the procedure will be documented. The main outcome is anesthesia quality during the procedure, with secondary outcomes including changes in monitoring indices and safety measures. The total study period covers the procedure and 24-hour follow-up for complications.
CONDITIONS
Brief Title
Anesthesia Induction Scheme for Painless Gastrointestinal Endoscopy Patients Based on Nociceptive Stimulation Monitoring
Who Can Participate
Age: 18Years - 60Years
All Genders
Eligibility Criteria
You may qualify if you...
- Aged 18-60 years old
- American Society of Anesthesiologists (ASA) Class I-III
- Body mass index (BMI) between 18 and 30 kg/m²
- Scheduled for elective gastroscopy or colonoscopy
- Willing to comply with study procedures and provide informed consent
You will not qualify if you...
- Pregnant or breastfeeding women
- Allergy to sedatives or anesthetic drugs or severe anesthetic risks
- Chronic preoperative pain or history of substance abuse
- Severe neurological diseases such as stroke, hemiplegia, seizures, or epilepsy
- Difficult airway conditions like limited mouth opening or neck/jaw mobility restrictions
- Respiratory diseases including bronchitis, asthma, COPD, or acute respiratory infections
- Chronic throat conditions affecting normal function
- Esophageal diseases causing swallowing difficulty or reflux
- Poorly controlled life-threatening cardiovascular diseases
- Liver dysfunction (Child-Pugh grade C or above), acute upper GI bleeding with shock, severe anemia, or gastrointestinal obstruction with retained gastric contents
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Duration of the endoscopy procedure
Participants undergo painless gastrointestinal endoscopy with EEG bispectral index monitoring (qCON and qNOX) during the procedure to assess sedation and analgesia status.
1 visit (in-person)
Long-term Monitoring
Duration - 24 hours after procedure
Participants are monitored for adverse events and complications after the endoscopy procedure.
1 visit or contact within 24 hours post-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
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Research Team
Q
Qin Liu
S
Su Min
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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