NociceptionNCT06777589
Quantitative Consciousness Index Monitoring (qNOX) of Sedation During Endoscopy
A study testing Monitoring of anesthesia depth in people with Nociception, run by Min Su at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nociception
- What is being tested?
- Monitoring of anesthesia depth
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
- Clear understanding and voluntary participation in this study, with informed consent signed.
Who cannot join
- 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;
- Patients with preoperative chronic pain or a history of substance abuse;
- Patients with severe neurological diseases such as stroke, hemiplegia, convulsions, epilepsy, etc.;
Show all 9Show fewer
- Patients with known difficult airways such as limited mouth opening, restricted neck and jaw movement, rheumatoid spondylitis, temporomandibular joint arthritis, etc.;
- Patients with potentially life-threatening circulatory and respiratory diseases that are not adequately controlled, such as uncontrolled severe hypertension, severe arrhythmias, unstable angina pectoris, acute respiratory infections, asthma exacerbations, etc.;
- Patients with liver dysfunction (Child-Pugh Class C or higher), acute upper gastrointestinal bleeding with shock, severe anemia, gastrointestinal obstruction with gastric retention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Su Min contact
China1 site, 1 recruiting
- Recruiting
China,Chongqing The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Qin Liu, MD, 17713733719, 17713733719@163.com
About this study
Official title: Exploration of the Range of the Quantitative Nociception Index (qNOX) During Gastrointestinal Endoscopy Under Intravenous Sedation: a Multicenter Clinical Study
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.
Read the detailed description
This is a multicenter clinical study. Study Objective: To explore the reasonable range of the qNOX and the optimal timing for gastroscopy and colonoscopy during intravenous sedation-assisted endoscopic examinations. Study Protocol: A total of 900 patients undergoing intravenous sedation-assisted digestive endoscopy in the outpatient clinics of the participating institutions were selected. Among them, 450 patients undergoing gastroscopy were divided into a propofol group (GP group) and a propofol combined with low-dose sufentanil group (GSP group); 450 patients undergoing colonoscopy were divided into a propofol group (CP group) and a propofol combined with low-dose sufentanil group (CSP group). The bispectral index monitor (Apollo-9000A) was used to monitor the qCON and qNOX of patients during intravenous sedation-assisted digestive endoscopy. The values of 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.
- Conditions
- Nociception
- Being tested
- Monitoring of anesthesia depth
- Keywords
- Nociception, endoscopy, Depth of anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring of anesthesia depthDevice
During gastroscopy and colonoscopy procedures, the Bispectral Index Monitor (Apollo-9000A) is utilized to monitor patients' quantitative consciousness index (qCON) and quantitative nociception index (qNOX).
| Study group | Role | What they receive |
|---|---|---|
| Group Ⅰ: Propofol Gastroscopy Group (GP Group) | Experimental | During the gastroscopy procedure, the Bispectral Index Monitor (Apollo-9000A) was utilized to monitor patients' qCON and qNOX. The anesthesia sedation protocol involved induction with propofol, with an induction dose ranging from 1.5 to 2.5 mg/kg. The propofol was administered using a syringe pump at an infusion rate of 300 ml/h. During the examination, propofol was infused at a rate of 4 to 6 mg/kg·h. Receives: Device: Monitoring of anesthesia depth |
| Group Ⅱ: Propofol Combined with Low-dose Sufentanil Gastroscopy Group (GSP Group) | Experimental | During the gastroscopy procedure, the Bispectral Index Monitor (Apollo-9000A) was used to monitor patients' qCON and qNOX. The anesthesia sedation protocol involved induction with a combination of propofol and a low dose of sufentanil. Initially, sufentanil 5μg (1μg/mL) was administered intravenously, followed by the initiation of propofol infusion one minute later using a syringe pump. The induction dose of propofol was 1.5 to 2.5 mg/kg, with a propofol infusion rate of 300 ml/h. During the examination, propofol was infused at a rate of 4 to 6 mg/kg·h. Receives: Device: Monitoring of anesthesia depth |
| Group Ⅲ: Propofol Colonoscopy Group (CP Group) | Experimental | During the Colonoscopy procedure, the Bispectral Index Monitor (Apollo-9000A) was utilized to monitor patients' qCON and qNOX. The anesthesia sedation protocol involved induction with propofol, with an induction dose ranging from 1.5 to 2.5 mg/kg. The propofol was administered using a syringe pump at an infusion rate of 300 ml/h. During the examination, propofol was infused at a rate of 4 to 6 mg/kg·h. Receives: Device: Monitoring of anesthesia depth |
| Group IV: Propofol Combined with Low-dose Sufentanil Colonoscopy Group (CSP Group) | Experimental | During the Colonoscopy procedure, the Bispectral Index Monitor (Apollo-9000A) was used to monitor patients' qCON and qNOX. The anesthesia sedation protocol involved induction with a combination of propofol and a low dose of sufentanil. Initially, sufentanil 5μg (1μg/mL) was administered intravenously, followed by the initiation of propofol infusion one minute later using a syringe pump. The induction dose of propofol was 1.5 to 2.5 mg/kg, with a propofol infusion rate of 300 ml/h. During the examination, propofol was infused at a rate of 4 to 6 mg/kg·h. Receives: Device: Monitoring of anesthesia depth |
What is being measured
The primary outcome is the main question the study is designed to answer.
The value of qNOX
The value of qNOX when the gastroscope passes through the pharynx or the colonoscope passes through the anus.
Measured: Start of the procedure，when the gastroscope passes through the pharynx or the colonoscope passes through the anus.
Secondary outcomes (10)
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).
Measured: Up to 1 hours, from the moment the patient enters the endoscopy procedure room until they exit it
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.
Measured: Up to 1 hours, from the moment the patient enters the endoscopy procedure room until they exit it
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).
Measured: Up to 1 hours, from the moment the patient enters the endoscopy procedure room until they exit it
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.
Measured: Up to 1 hours, from the moment the patient enters the endoscopy procedure room until they exit it
The values of HR at different time
The Values of HR 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).
Measured: Up to 1 hours, from the moment the patient enters the endoscopy procedure room until they exit it
The values of HR under special events
The values of HR during coughing, body movement, biopsy, and polypectomy that occurred during the examination.
Measured: Up to 1 hours, from the moment the patient enters the endoscopy procedure room until they exit it
The values of MOAA/S at different time
The Values of 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), 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).
Measured: Up to 1 hours, from the moment the patient enters the endoscopy procedure room until they exit it
The values of MOAA/S under special events
The values of HR during coughing, body movement, biopsy, and polypectomy that occurred during the examination.
Measured: Up to 1 hours, from the moment the patient enters the endoscopy procedure room until they exit it
Adverse events
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.
Measured: Up to 1 hours, from the moment the patient enters the endoscopy procedure room until they exit it
Adverse events and complications after examination
Bleeding, dizziness, blurred vision, nausea, vomiting, abdominal pain, abdominal distension were followed up 24h after the examination
Measured: 24 hours after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start1 Jun 2025 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NociceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Min Su
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Min Su, First Affiliated Hospital of Chongqing Medical University
- Investigators
- Su Min, Study director, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777589
- Sponsor's protocol ID
- 202410901
- Status last verified
- May 2025
- First submitted
- 2 Jan 2025
- Last updated
- 2 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Range of the Quantitative Nociception Index (qNOX) During Gastrointestinal Endoscopy Under Intravenous Sedation: a Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT06777589
- Acronym / sponsor ID
- 202410901
- Conditions
- Nociception
- Keywords
- Nociception, endoscopy, Depth of anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Min SuUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multicenter clinical study. Study Objective: To explore the reasonable range of the qNOX and the optimal timing for gastroscopy and colonoscopy during intravenous sedation-assisted endoscopic examinations. Study Protocol: A total of 900 patients undergoing intravenous sedation-assisted digestive endoscopy in the outpatient clinics of the participating institutions were selected. Among them, 450 patients undergoing gastroscopy were divided into a propofol group (GP group) and a propofol combined with low-dose sufentanil group (GSP group); 450 patients undergoing colonoscopy were divided into a propofol group (CP group) and a propofol combined with low-dose sufentanil group (CSP group). The bispectral index monitor (Apollo-9000A) was used to monitor the qCON and qNOX of patients during intravenous sedation-assisted digestive endoscopy. The values of 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group Ⅰ: Propofol Gastroscopy Group (GP Group) | Experimental | Device: Monitoring of anesthesia depthDuring the gastroscopy procedure, the Bispectral Index Monitor (Apollo-9000A) was utilized to monitor patients' qCON and qNOX. The anesthesia sedation protocol involved induction with propofol, with an induction dose ranging from 1.5 to 2.5 mg/kg. The propofol was administered using a syringe pump at an infusion rate of 300 ml/h. During the examination, propofol was infused at a rate of 4 to 6 mg/kg·h. |
| Group Ⅱ: Propofol Combined with Low-dose Sufentanil Gastroscopy Group (GSP Group) | Experimental | Device: Monitoring of anesthesia depthDuring the gastroscopy procedure, the Bispectral Index Monitor (Apollo-9000A) was used to monitor patients' qCON and qNOX. The anesthesia sedation protocol involved induction with a combination of propofol and a low dose of sufentanil. Initially, sufentanil 5μg (1μg/mL) was administered intravenously, followed by the initiation of propofol infusion one minute later using a syringe pump. The induction dose of propofol was 1.5 to 2.5 mg/kg, with a propofol infusion rate of 300 ml/h. During the examination, propofol was infused at a rate of 4 to 6 mg/kg·h. |
| Group Ⅲ: Propofol Colonoscopy Group (CP Group) | Experimental | Device: Monitoring of anesthesia depthDuring the Colonoscopy procedure, the Bispectral Index Monitor (Apollo-9000A) was utilized to monitor patients' qCON and qNOX. The anesthesia sedation protocol involved induction with propofol, with an induction dose ranging from 1.5 to 2.5 mg/kg. The propofol was administered using a syringe pump at an infusion rate of 300 ml/h. During the examination, propofol was infused at a rate of 4 to 6 mg/kg·h. |
| Group IV: Propofol Combined with Low-dose Sufentanil Colonoscopy Group (CSP Group) | Experimental | Device: Monitoring of anesthesia depthDuring the Colonoscopy procedure, the Bispectral Index Monitor (Apollo-9000A) was used to monitor patients' qCON and qNOX. The anesthesia sedation protocol involved induction with a combination of propofol and a low dose of sufentanil. Initially, sufentanil 5μg (1μg/mL) was administered intravenously, followed by the initiation of propofol infusion one minute later using a syringe pump. The induction dose of propofol was 1.5 to 2.5 mg/kg, with a propofol infusion rate of 300 ml/h. During the examination, propofol was infused at a rate of 4 to 6 mg/kg·h. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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;
- Clear understanding and voluntary participation in this study, with informed consent signed.
Key exclusion criteria (9 listed)
- 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;
- Patients with preoperative chronic pain or a history of substance abuse;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring of anesthesia depthDuring gastroscopy and colonoscopy procedures, the Bispectral Index Monitor (Apollo-9000A) is utilized to monitor patients' quantitative consciousness index (qCON) and quantitative nociception index (qNOX). | Device | Group IV: Propofol Combined with Low-dose Sufentanil Colonoscopy Group (CSP Group), Group Ⅰ: Propofol Gastroscopy Group (GP Group), Group Ⅱ: Propofol Combined with Low-dose Sufentanil Gastroscopy Group (GSP Group), Group Ⅲ: Propofol Colonoscopy Group (CP Group) |
Primary outcome
The value of qNOX
Time frame: Start of the procedure，when the gastroscope passes through the pharynx or the colonoscope passes through the anus.
The value of qNOX when the gastroscope passes through the pharynx or the colonoscope passes through the anus.
10 secondary outcomes
The values of qCON 、 qNOX at different time
Time frame: Up to 1 hours, from the moment the patient enters the endoscopy procedure room until they exit it
The values of qCON 、 qNOX under special events
Time frame: Up to 1 hours, from the moment the patient enters the endoscopy procedure room until they exit it
The values of SBP、DBP、 MAP at different time
Time frame: Up to 1 hours, from the moment the patient enters the endoscopy procedure room until they exit it
The values of SBP、DBP、 MAP under special events
Time frame: Up to 1 hours, from the moment the patient enters the endoscopy procedure room until they exit it
The values of HR at different time
Time frame: Up to 1 hours, from the moment the patient enters the endoscopy procedure room until they exit it
The values of HR under special events
Time frame: Up to 1 hours, from the moment the patient enters the endoscopy procedure room until they exit it
The values of MOAA/S at different time
Time frame: Up to 1 hours, from the moment the patient enters the endoscopy procedure room until they exit it
The values of MOAA/S under special events
Time frame: Up to 1 hours, from the moment the patient enters the endoscopy procedure room until they exit it
Adverse events
Time frame: Up to 1 hours, from the moment the patient enters the endoscopy procedure room until they exit it
Adverse events and complications after examination
Time frame: 24 hours after procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Su Min contact
Su Min study director
First Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring of anesthesia depth in people with Nociception, run by Min Su at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qin Liu (17713733719, 17713733719@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The value of qNOX (time frame: Start of the procedure，when the gastroscope passes through the pharynx or the colonoscope passes through the anus.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2025.