An observational study in Depth of Anesthesia, Nociception and Painless Gastrointestinal Endoscopy, sponsored by Min Su. Recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-03-06.
Sponsored by Min Su · Observational
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.
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.
Min Su is the lead sponsor of 12 studies on the registry; 9 are open to participants now.
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Aged 18-60 years old;Individuals scheduled for elective gastroscopy and colonoscopy examinations
Exclusion Criteria:
This study used an EEG bispectral index monitor (Apolo 9000A) to monitor quantitative consciousness (qCON) index and quantitative nociceptive (qNOX) index during gastroscopy. Anesthesia induction was performed using 1.5-2.5mg/kg propofol and 3-5 μ g sufentanil; The injection speed of propofol is between 120s and 180s. When the patient's consciousness disappears (the patient's eyelash reflex disappears, and there is no response to calls and external stimuli), and the Modified Alertness/Sedation (MOAAS) score is ≤ 1, gastroscopy examination will begin. During the examination, propofol 4-12mg/kg. h will be pumped to make MOAA/S ≤ 1, and there will be no body movement reaction.
Device: EEG monitoring
This study used an EEG bispectral index monitor (Apolo 9000A) to monitor quantitative consciousness (qCON) index and quantitative nociceptive (qNOX) index during Colonoscopy. Anesthesia induction was performed using 1.5-2.5mg/kg propofol and 3-5 μ g sufentanil; The injection speed of propofol is between 120s and 180s. When the patient's consciousness disappears (the patient's eyelash reflex disappears, and there is no response to calls and external stimuli), and the Modified Alertness/Sedation (MOAAS) score is ≤ 1, Colonoscopy examination will begin. During the examination, propofol 4-12mg/kg. h will be pumped to make MOAA/S ≤ 1, and there will be no body movement reaction.
Device: 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.
Anesthesia quality
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)
Time frame: during the procedure
The values of qCON 、 qNOX、MAP、HR、SPO2 、and MOAA/S at different time points
The Values of qCON 、 qNOX、MAP、HR、SPO2 and MOAA/S at different time points during gastroscopy and enteroscopy ① Time points for gastroscopy: Baseline value (T0), Loss of consciousness (T1), Before insertion of the gastroscope (T2), Passage of the gastroscope through the pharynx (T3), After insertion of the gastroscope (T4), Withdrawal of the gastroscope to the pharynx (T5), Examination completion (T6), Admission to recovery room (T7), Awakening (T8), Discharge from recovery room (T9). ② Time points for colonoscopy: Baseline value (T0), Loss of consciousness (T1), Before insertion of the colonoscope (T2), After insertion of the colonoscope into the anus (S3), Descending colon (T4), Splenic flexure (T5), Hepatic flexure (T6), Examination completion (T7), Admission to recovery room (T8), Awakening (T9), Discharge from recovery room (T10).
Time frame: during the procedure
The values of qCON 、 qNOX、MAP、HR、SPO2 under special events
During gastroscopy and colonoscopy , the values of qCON 、 qNOX、MAP、HR、SPO2 are recorded when coughing, body movement, polypectomy, or biopsy occur.
Time frame: during the procedure
Adverse event
Adverse events during gastroscopy and enteroscopy were recorded, including hypotension, hypertension, tachycardia, bradycardia, respiratory depression, hypoxemia, cough, body movement, nausea, vomiting, hiccup, injection pain, abdominal pain, abdominal distension, reflux aspiration.
Time frame: during the procedure
Adverse events and complications after examination
Bleeding, dizziness, blurred vision, nausea, vomiting, abdominal pain, abdominal distension were followed up 24h after the examination
Time frame: 24 hours after procedure
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