China,Chongqing The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
Location status: Recruiting
NCT Number: NCT06604156
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.
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Request Info18 year–60 year
All sexes
Observational
Chongqing, Chongqing Municipality, 400016, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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)
Time frame: during the procedure
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
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 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: 24 hours after procedure
Bleeding, dizziness, blurred vision, nausea, vomiting, abdominal pain, abdominal distension were followed up 24h after the examination
Contact information is provided by the study sponsor or research team.
Min Su
Other
The Effect of the Nociception Index (qNOX) in Painless Gastrointestinal Endoscopy :a Clinical Study
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