Quantitative Consciousness Index Monitoring (qNOX) of Sedation During Endoscopy
ConditionNociception
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorMin Su
About this trial
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. This device enables more precise monitoring of anesthesia depth, quantification of patients' anesthesia analgesia and stress levels, and reliable monitoring of responses to noxious stimulation. During tracheal intubation for general anesthesia, when the qCON value falls within the range of 40 to 60 and the qNOX value is between 30 and 50, it indicates that the patient is in an appropriate state of sedation and analgesia. However, there is currently no universally acknowledged standard for the optimal qNOX reference range during conscious sedation endoscopy. Therefore, this study utilizes the noxious stimulation response index (qNOX) to monitor noxious stimulation during the procedure, aiming to identify the best timing for inserting the endoscope during conscious sedation endoscopy and explore the appropriate range of qNOX for this purpose.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age between 18 and 60 years old;
ASA-PS (American Society of Anesthesiologists Physical Status) classification of I to II;
Body Mass Index (BMI): 18 to 28 kg/m²;
Patients undergoing diagnostic and therapeutic procedures under sedation for lower gastrointestinal endoscopy;
Disqualifiers
Patients requiring complex endoscopic techniques for diagnosis and treatment;
Patients who have participated in other clinical trials in the past three months;
Pregnant and lactating patients;
Patients with allergies to sedatives/anesthetics and other severe anesthesia risks;
Trial design
Design model
Parallel
Treatments tested in this trial
Monitoring of anesthesia depth
DeviceDuring gastroscopy and colonoscopy procedures, the Bispectral Index Monitor (Apollo-9000A) is utilized to monitor patients' quantitative consciousness index (qCON) and quantitative nociception index (qNOX).
Treatment groups
900 Participants
are divided into 4 treatment groupsGroup A: Group Ⅰ: Propofol Gastroscopy Group (GP Group)Experimental treatment 1 intervention
Group B: Group Ⅱ: Propofol Combined with Low-dose Sufentanil Gastroscopy Group (GSP Group)Experimental treatment 1 intervention
Group C: Group Ⅲ: Propofol Colonoscopy Group (CP Group)Experimental treatment 1 intervention
Group D: Group IV: Propofol Combined with Low-dose Sufentanil Colonoscopy Group (CSP Group)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The value of qNOX
The value of qNOX when the gastroscope passes through the pharynx or the colonoscope passes through the anus.
Time frame
Start of the procedure，when the gastroscope passes through the pharynx or the colonoscope passes through the anus.Secondary outcomes
1
The values of qCON 、 qNOX at different time
The Values of qCON 、 qNOX 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), Examination completion (T5), Awakening (T6), Discharge from recovery room (T7). 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 (T3), Descending colon (T4), Splenic flexure (T5), Hepatic flexure (T6), Examination completion (T7), Awakening (T8), Discharge from recovery room (T9).
Time frame
Up to 1 hours, from the moment the patient enters the endoscopy procedure room until they exit it2
The values of qCON 、 qNOX under special events
The values of qCON, qNOX score during coughing, body movement, biopsy, and polypectomy that occurred during the examination.
Time frame
Up to 1 hours, from the moment the patient enters the endoscopy procedure room until they exit it3
The values of SBP、DBP、 MAP at different time
The Values of SBP、DBP、 MAP 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), Examination completion (T5), Awakening (T6), Discharge from recovery room (T7). 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 (T3), Descending colon (T4), Splenic flexure (T5), Hepatic flexure (T6), Examination completion (T7), Awakening (T8), Discharge from recovery room (T9).
Time frame
Up to 1 hours, from the moment the patient enters the endoscopy procedure room until they exit it4
The values of SBP、DBP、 MAP under special events
The values of SBP、DBP、 MAP during coughing, body movement, biopsy, and polypectomy that occurred during the examination.
Time frame
Up to 1 hours, from the moment the patient enters the endoscopy procedure room until they exit itSponsors and contacts
Click on the lead sponsor to view all of their trials.
Min Su
Lead sponsor
First Affiliated Hospital of Chongqing Medical University
Sponsor institution
Source ClinicalTrials.gov