Quantitative Consciousness Index Monitoring (qNOX) of Sedation During Endoscopy

NCT06777589 | Recruiting

• 1 other identifier: 202410901
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

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.

Conditions

Nociception

Keywords

Nociception; endoscopy; Depth of anesthesia

Outcome Measures

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.

  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

  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

  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

  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

  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

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

Study Arms (4)

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.

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.

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.

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.

Device: Monitoring of anesthesia depth

Interventions

Monitoring of anesthesia depth 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); 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)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Min Su: lead

Study Sites (1)

China,Chongqing The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

RECRUITING

Study Officials

• Su Min

  First Affiliated Hospital of Chongqing Medical University

  STUDY DIRECTOR

Central Study Contacts

Qin Liu

CONTACT

17713733719; 17713733719@163.com

Su Min

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 16, 2025
• Study Start: June 1, 2025
• Primary Completion: July 31, 2025
• Study Completion: August 31, 2025
• Last Updated: June 2, 2025

Record last verified: 2025-05

Locations

CN (1)