Anesthesia Induction Scheme for Painless Gastrointestinal Endoscopy Patients Based on Nociceptive Stimulation Monitoring

NCT06604156 | Recruiting

• 1 other identifier: 2024-239-01
• Study Type: observational
• Target: 220
• 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. 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.

Conditions

Depth of Anesthesia; Nociception; Painless Gastrointestinal Endoscopy

Keywords

Painless Gastrointestinal endoscopy; depth of anesthesia; nociception

Outcome Measures

Primary Outcomes (1)

• Anesthesia quality

  The quality of anesthesia and sedation during gastroscopy through the throat or colonoscopy through the anus (criteria: HR and SBP fluctuations within 10%; no movement or coughing response)

  during the procedure

Secondary Outcomes (4)

• The values of qCON 、 qNOX、MAP、HR、SPO2 、and MOAA/S at different time points

  during the procedure

• The values of qCON 、 qNOX、MAP、HR、SPO2 under special events

  during the procedure

• Adverse event

  during the procedure

• Adverse events and complications after examination

  24 hours after procedure

Study Arms (2)

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.

Device: EEG monitoring

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.

Device: EEG monitoring

Interventions

EEG monitoring DEVICE

During gastrointestinal endoscopy, electroencephalogram (EEG) monitoring will be conducted using qCON and qNOX technologies to assess patients\' sedation and analgesia status while they undergo painless gastrointestinal endoscopy. This will be combined with visual assessments (such as cough reflex, respiratory depression, and limb movement) and clinical physiological monitoring (including vital signs and pulse oximetry) to explore and establish a stable and optimal depth of sedation for anesthesia.

Colonoscopy group; Gastroscopy group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Aged 18-60 years old;Individuals scheduled for elective gastroscopy and colonoscopy examinations

You may qualify if:

• 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

You may not qualify if:

• Pregnant or breastfeeding women;
• Individuals with allergies to sedatives/anesthetic drugs or other severe anesthetic risks;
• Patients with chronic preoperative pain or a history of substance abuse;
• Individuals with severe neurological diseases, such as stroke, hemiplegia, seizures, epilepsy, etc.;
• Patients with clearly difficult airways, such as those with limited mouth opening, neck or jaw mobility restrictions, rheumatoid arthritis, or temporomandibular joint disorders;
• Individuals with respiratory diseases, such as bronchitis, asthma, chronic obstructive pulmonary disease, or acute respiratory infections, which may lead to increased airway sensitivity;
• Patients with chronic pharyngitis, laryngitis, laryngeal edema, or recurrent laryngeal nerve paralysis that may affect normal throat function;
• Individuals with esophagitis, esophageal strictures, or esophageal motility disorders that may cause difficulty swallowing or reflux;
• Patients with poorly controlled life-threatening cardiovascular diseases, such as uncontrolled severe hypertension, severe arrhythmias, or unstable angina; 10.10.Patients with liver dysfunction (Child-Pugh grade C or above), acute upper gastrointestinal bleeding with shock, severe anemia, or gastrointestinal obstruction with retained gastric contents.

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: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: September 19, 2024
• Study Start: September 1, 2024
• Primary Completion: August 31, 2025
• Study Completion: October 31, 2025
• Last Updated: March 6, 2025

Record last verified: 2025-03

Locations

CN (1)