Monitoring pain response during painless gastrointestinal endoscopy
Official title: The Effect of the Nociception Index (qNOX) in Painless Gastrointestinal Endoscopy :a Clinical Study
Run by First Affiliated Hospital of Chongqing Medical University · NCT06604156 · Data updated 2026-11-12
This study is testing a new device to see how well different sedation methods work for making patients comfortable during painless gastrointestinal endoscopy procedures.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 220 (estimated) |
| Sponsor | First Affiliated Hospital of Chongqing Medical University Academic / other |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Status | Recruiting |
| Started | September 1, 2024 |
| Main results expected | August 31, 2025 |
| Study ends | October 31, 2025 |
| Registry record updated | March 6, 2025 |
| Trial ID | NCT06604156 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-60 with ASA Class I-III who are scheduled for elective gastroscopy or colonoscopy.
✕Probably not a fit
Patients who are pregnant, have severe neurological diseases, or significant respiratory issues may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to explore the optimal sedation quality for painless gastrointestinal endoscopy by utilizing a new monitoring device that assesses nociceptive responses through electroencephalographic (EEG) activity. A total of 220 patients scheduled for elective gastroscopy and colonoscopy will be monitored using the quantitative consciousness (qCON) and quantitative nociception (qNOX) indices. The study will track changes in these indices alongside vital signs and sedation scores to evaluate the effectiveness of sedation during the procedures. The goal is to enhance patient comfort and safety during gastrointestinal endoscopy.
Why it matters
Potential benefit: If successful, this study could lead to improved sedation techniques that enhance patient comfort during gastrointestinal procedures.
How similar studies have gone: While the use of EEG monitoring in sedation is established, the specific application of qCON and qNOX indices in this context is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 18-60 years old; 2. American Society of Anesthesiologists (ASA) Class I-III; 3. Body mass index (BMI): 18-30 kg/m\^2; 4. Individuals scheduled for elective gastroscopy and colonoscopy examinations; 5. Willing to comply with the experimental procedures and voluntarily sign the informed consent form Exclusion Criteria: 1. Pregnant or breastfeeding women; 2. Individuals with allergies to sedatives/anesthetic drugs or other severe anesthetic risks; 3. Patients with chronic preoperative pain or a history of substance abuse; 4. Individuals with severe neurological diseases, such as stroke, hemiplegia, seizures, epilepsy, etc.; 5. Patients with clearly difficult airways, such as those with limited mouth opening, neck or jaw mobility restrictions, rheumatoid arthritis, or temporomandibular joint disorders; 6. Individuals with respiratory diseases, such as bronchitis, asthma, chronic obstructive pulmonary disease, or acute respiratory infections, which may lead to increased airway sensitivity; 7. Patients with chronic pharyngitis, laryngitis, laryngeal edema, or recurrent laryngeal nerve paralysis that may affect normal throat function; 8. Individuals with esophagitis, esophageal strictures, or esophageal motility disorders that may cause difficulty swallowing or reflux; 9. Patients with poorly controlled life-threatening cardiovascular diseases, such as uncontrolled severe hypertension, severe arrhythmias, or unstable angina; 10.10.Patients with liver dysfunction (Child-Pugh grade C or above), acute upper gastrointestinal bleeding with shock, severe anemia, or gastrointestinal obstruction with retained gastric contents.
Where it's running
-
China,Chongqing The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China Recruiting
Study contacts
- Study coordinator: Qin Liu
- Email: 17713733719@163.com
- Phone: 17713733719
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Pain monitoring with ANI during rapid sequence induction
This study tests whether the Analgesia Nociception Index (ANI) can measure pain during rapid sequence induction in adults undergoing tracheal intubation.
-
AI-assisted analgesia copilot to guide remifentanil dosing during general anesthesia
This project will test an AI 'co-pilot' that monitors multiple physiological signals during general anesthesia to guide remifentanil dosing and reduce over- or under-dosing for adults having elective surgeries of 2–4 hours.
-
qNOX/qCON EEG monitoring to guide sedation during gastroscopy and colonoscopy
This trial tests whether qNOX and qCON EEG monitoring can better guide sedation and pain response for adults having propofol or propofol-plus-sufentanil gastroscopy and colonoscopy under IV sedation.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.