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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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.;
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  • 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
  • China,Chongqing The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

    Qin Liu, MD, 17713733719, 17713733719@163.com

    Recruiting

Other trials in China

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 groups in NCT06777589
Study groupRoleWhat they receive
Group Ⅰ: Propofol Gastroscopy Group (GP Group)ExperimentalDuring 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)ExperimentalDuring 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)ExperimentalDuring 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)ExperimentalDuring 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.

  1. 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)
  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).

    Measured: Up to 1 hours, from the moment the patient enters the endoscopy procedure room until they exit it

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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.

  1. First posted16 Jan 2025
  2. Study start1 Jun 2025 (estimated)
  3. Primary completion31 Jul 2025 (estimated)
  4. Study completion31 Aug 2025 (estimated)

Resources

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)
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

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.

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