Quantitative Consciousness Index Monitoring (qNOX) of Sedation During Endoscopy

NCT ID: NCT06777589

Last Updated: 2025-06-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2025-08-31

Brief 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. 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.

Conditions

Nociception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Group Ⅰ: Propofol Gastroscopy Group (GP Group)

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.

Group Type: EXPERIMENTAL

Monitoring of anesthesia depth

Intervention Type: DEVICE

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).

Group Ⅱ: Propofol Combined with Low-dose Sufentanil Gastroscopy Group (GSP Group)

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.

Group Type: EXPERIMENTAL

Monitoring of anesthesia depth

Intervention Type: DEVICE

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).

Group Ⅲ: Propofol Colonoscopy Group (CP Group)

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.

Group Type: EXPERIMENTAL

Monitoring of anesthesia depth

Intervention Type: DEVICE

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).

Group IV: Propofol Combined with Low-dose Sufentanil Colonoscopy Group (CSP Group)

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.

Group Type: EXPERIMENTAL

Monitoring of anesthesia depth

Intervention Type: DEVICE

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).

Interventions

Monitoring of anesthesia depth

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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age between 18 and 60 years old;

2. ASA-PS (American Society of Anesthesiologists Physical Status) classification of I to II;

3. Body Mass Index (BMI): 18 to 28 kg/m²;

4. Patients undergoing diagnostic and therapeutic procedures under sedation for lower gastrointestinal endoscopy;

5. Clear understanding and voluntary participation in this study, with informed consent signed.

Exclusion Criteria

1. Patients requiring complex endoscopic techniques for diagnosis and treatment;

2. Patients who have participated in other clinical trials in the past three months;

3. Pregnant and lactating patients;

4. Patients with allergies to sedatives/anesthetics and other severe anesthesia risks;

5. Patients with preoperative chronic pain or a history of substance abuse;

6. Patients with severe neurological diseases such as stroke, hemiplegia, convulsions, epilepsy, etc.;

7. Patients with known difficult airways such as limited mouth opening, restricted neck and jaw movement, rheumatoid spondylitis, temporomandibular joint arthritis, etc.;

8. 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.;

9. Patients with liver dysfunction (Child-Pugh Class C or higher), acute upper gastrointestinal bleeding with shock, severe anemia, gastrointestinal obstruction with gastric retention.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Min Su

OTHER

Sponsor Role: lead

Responsible Party

Min Su

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Su Min

Role: STUDY_DIRECTOR

First Affiliated Hospital of Chongqing Medical University

Locations

China,Chongqing The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qin Liu

Role: CONTACT

17713733719@163.com

17713733719

Su Min

Role: CONTACT

Facility Contacts

Qin Liu, MD

Role: primary

17713733719@163.com

17713733719

Other Identifiers

202410901

Identifier Type: -

Identifier Source: org_study_id