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Clinical Trials in China / NCT06604156
Recruiting Observational

Anesthesia Induction Scheme for Painless Gastrointestinal Endoscopy Patients Based on Nociceptive Stimulation Monitoring

NCT06604156 · tracked via the Priya Life Science China tracker
Sponsor
Min Su
Phase
Observational
Started
2024-09-01
Last updated
2025-03-06

Condition(s) studied

Depth of AnesthesiaNociceptionPainless Gastrointestinal Endoscopy

Investigational drug(s) / intervention(s)

EEG monitoring

EEG monitoring: During gastrointestinal endoscopy, electroencephalogram (EEG) monitoring will be conducted using qCON and qNOX technologies to assess patients\' sedation and analgesia status while they undergo painless gastrointestinal endoscopy. This will be combined with visual assessments (such as cough reflex, respiratory depression, and limb movement) and clinical physiological monitoring (including vital signs and pulse oximetry) to explore and establish a stable and optimal depth of sedation for anesthesia.

Study summary

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. However, in the context of sedation for gastrointestinal endoscopy, how the dynamic changes of the quantitative consciousness index (qCON) and the quantitative nociception index (qNOX) reflect the depth of sedation and nociceptive response remains unclear. Safe and effective sedation monitoring includes both direct visual monitoring and physiological monitoring, that is, monitoring the patient's hemodynamics and depth of sedation. This study utilizes qCON and qNOX monitoring to assess the sedation and analgesic states of patients undergoing painless gastroenterological endoscopy. By combining visual assessment (cough reflex, respiratory depression, and limb movement) with clinical physiological monitoring (vital signs monitoring and pulse oximetry), the aim is to explore the optimal sedation range for gastrointestinal endoscopy under sedation, providing new anesthesia monitoring tools for clinical use.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Anesthesia quality — during the procedure
    The quality of anesthesia and sedation during gastroscopy through the throat or colonoscopy through the anus (criteria: HR and SBP fluctuations within 10%; no movement or coughing response)

Trial sites (1)

FacilityCityRegionStatus
China,Chongqing The First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality Recruiting

More Min Su trials in China

Subanesthetic Esketamine in Modified ECT for Severe Depression in Adolescents: Clinical and Mechanistic Study Recruiting
Construction and Clinical Validation Study of a Prediction Model for Depression After Ischemic Stroke Recruiting
Quantitative Consciousness Index Monitoring (qNOX) of Sedation During Endoscopy Recruiting

Other trials for the same condition

Quantitative Consciousness Index Monitoring (qNOX) of Sedation During Endoscopy Recruiting
Anesthesia Maintenance With Target-controlled Infusion of Propofol and Remifentanil at Fixed Ratio Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06604156 on ClinicalTrials.gov ↗ ← All trials in China