Clinical trial NCT06604156: Anesthesia Induction Scheme for Painless Gastrointestinal Endoscopy Patients Based on Nociceptive Stimulation Monitoring
Official title: The Effect of the Nociception Index (qNOX) in Painless Gastrointestinal Endoscopy :a Clinical Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Depth of Anesthesia
Nociception
Painless Gastrointestinal Endoscopy
Keywords: Painless Gastrointestinal endoscopy
depth of anesthesia
nociception
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Aged 18-60 years old;Individuals scheduled for elective gastroscopy and colonoscopy examinations

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.

Detailed description: This is a single-center, prospective, observational clinical study. Study Objective: To explore the optimal sedation quality for painless gastrointestinal endoscopy. Study Protocol: A total of 220 patients undergoing painless gastrointestinal endoscopy were selected, with 110 patients undergoing gastroscopy and 110 patients undergoing colonoscopy. The bispectral index monitor (Apollo-9000A) was used to monitor the qCON and qNOX values of patients during the painless gastrointestinal endoscopy. The changes in qCON, qNOX, SBP (systolic blood pressure), DBP (diastolic blood pressure), MAP (mean arterial pressure), HR (heart rate), SpO2 (peripheral capillary oxygen saturation), and MOAA/S (Modified Observer's Assessment of Alertness/Sedation) scores at different time points during gastroscopy and colonoscopy were observed and recorded. The occurrence of adverse events during and after the examinations was also documented.

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.

Primary outcomes:
measure: Anesthesia quality
timeFrame: during the procedure
Secondary outcomes:
measure: The values of qCON 、 qNOX、MAP、HR、SPO2 、and MOAA/S at different time points
timeFrame: during the procedure
measure: The values of qCON 、 qNOX、MAP、HR、SPO2 under special events
timeFrame: during the procedure
measure: Adverse event
timeFrame: during the procedure
measure: Adverse events and complications after examination
timeFrame: 24 hours after procedure
Other outcomes:
Locations:
city: Chongqing
country: China
facility: China,Chongqing The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Su Min
role: STUDY_DIRECTOR
References: