Quantitative Consciousness Index Monitoring (qNOX) of Sedation During Endoscopy

Official title

Exploration of the Range of the Quantitative Nociception Index (qNOX) During Gastrointestinal Endoscopy Under Intravenous Sedation: a Multicenter Clinical Study

Overview

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.

Interventions

• Device 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).

Primary outcome measures

• The value of qNOX [Time frame: Start of the procedure，when the gastroscope passes through the pharynx or the colonoscope passes through the anus.]

Secondary outcome measures (10)

• 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]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.;
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Other

Study locations

China · 1 center

• China,Chongqing The First Affiliated Hospital of Chongqing Medical University — Chongqing

Identifiers

NCT: NCT06777589 · 202410901

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗