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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
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• 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.

Locations
Other Locations
China
China,Chongqing The First Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
Contact Information
Primary
Qin Liu
17713733719@163.com
17713733719
Backup
Su Min
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2025-08-31
Participants
Target number of participants: 900
Treatments
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Min Su

This content was sourced from clinicaltrials.gov