The Effect of the Nociception Index (qNOX) in Painless Gastrointestinal Endoscopy :a Clinical Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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. However, in the context of sedation for gastrointestinal endoscopy, how the dynamic changes of the quantitative consciousness index (qCON) and the quantitative nociception index (qNOX) reflect the depth of sedation and nociceptive response remains unclear. Safe and effective sedation monitoring includes both direct visual monitoring and physiological monitoring, that is, monitoring the patient's hemodynamics and depth of sedation. This study utilizes qCON and qNOX monitoring to assess the sedation and analgesic states of patients undergoing painless gastroenterological endoscopy. By combining visual assessment (cough reflex, respiratory depression, and limb movement) with clinical physiological monitoring (vital signs monitoring and pulse oximetry), the aim is to explore the optimal sedation range for gastrointestinal endoscopy under sedation, providing new anesthesia monitoring tools for clinical use.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
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• Aged 18-60 years old;

• American Society of Anesthesiologists (ASA) Class I-III;

• Body mass index (BMI): 18-30 kg/m\^2;

• Individuals scheduled for elective gastroscopy and colonoscopy examinations;

• Willing to comply with the experimental procedures and voluntarily sign the informed consent form

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: 2024-09-01
Estimated Completion Date: 2025-10-31
Participants
Target number of participants: 220
Treatments
Gastroscopy group
This study used an EEG bispectral index monitor (Apolo 9000A) to monitor quantitative consciousness (qCON) index and quantitative nociceptive (qNOX) index during gastroscopy. Anesthesia induction was performed using 1.5-2.5mg/kg propofol and 3-5 μ g sufentanil; The injection speed of propofol is between 120s and 180s. When the patient's consciousness disappears (the patient's eyelash reflex disappears, and there is no response to calls and external stimuli), and the Modified Alertness/Sedation (MOAAS) score is ≤ 1, gastroscopy examination will begin. During the examination, propofol 4-12mg/kg. h will be pumped to make MOAA/S ≤ 1, and there will be no body movement reaction.
Colonoscopy group
This study used an EEG bispectral index monitor (Apolo 9000A) to monitor quantitative consciousness (qCON) index and quantitative nociceptive (qNOX) index during Colonoscopy. Anesthesia induction was performed using 1.5-2.5mg/kg propofol and 3-5 μ g sufentanil; The injection speed of propofol is between 120s and 180s. When the patient's consciousness disappears (the patient's eyelash reflex disappears, and there is no response to calls and external stimuli), and the Modified Alertness/Sedation (MOAAS) score is ≤ 1, Colonoscopy examination will begin. During the examination, propofol 4-12mg/kg. h will be pumped to make MOAA/S ≤ 1, and there will be no body movement reaction.
Related Therapeutic Areas
Sponsors
Leads: Min Su

This content was sourced from clinicaltrials.gov