Monitoring pain response during painless gastrointestinal endoscopy

The Effect of the Nociception Index (qNOX) in Painless Gastrointestinal Endoscopy :a Clinical Study

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
• Enrollment: 220 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: First Affiliated Hospital of Chongqing Medical University (Academic / other)
• Locations: 1 site (Chongqing, Chongqing Municipality)
• Trial ID: NCT06604156 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-60 with ASA Class I-III who are scheduled for elective gastroscopy or colonoscopy.

Not a fit: Patients who are pregnant, have severe neurological diseases, or significant respiratory issues may not benefit from this study.

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 performed: 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.

Eligibility 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 this trial is running

Chongqing, Chongqing Municipality

• China,Chongqing The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Qin Liu

Conditions Depth of Anesthesia; Nociception; Painless Gastrointestinal Endoscopy; Painless Gastrointestinal endoscopy; depth of anesthesia; nociception