NCT06604156 Anesthesia Induction Scheme for Painless Gastrointestinal Endoscopy Patients Based on Nociceptive Stimulation Monitoring
| NCT ID | NCT06604156 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Min Su |
| Condition | Depth of Anesthesia |
| Study Type | OBSERVATIONAL |
| Enrollment | 220 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2025-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 220 participants in total. It began in 2024-09-01 with a primary completion date of 2025-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Su Min
STUDY DIRECTOR
First Affiliated Hospital of Chongqing Medical University
Frequently Asked Questions
Who can join the NCT06604156 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Depth of Anesthesia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06604156 currently recruiting?
Yes, NCT06604156 is actively recruiting participants. Contact the research team at 17713733719@163.com for enrollment information.
Where is the NCT06604156 trial being conducted?
This trial is being conducted at Chongqing, China.
Who is sponsoring the NCT06604156 clinical trial?
NCT06604156 is sponsored by Min Su. The principal investigator is Su Min at First Affiliated Hospital of Chongqing Medical University. The trial plans to enroll 220 participants.