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

NCT ID: NCT06604156

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 220 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-10-31

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.

Detailed Description

This is a single-center, prospective, observational clinical study. Study Objective: To explore the optimal sedation quality for painless gastrointestinal endoscopy. Study Protocol: A total of 220 patients undergoing painless gastrointestinal endoscopy were selected, with 110 patients undergoing gastroscopy and 110 patients undergoing colonoscopy. The bispectral index monitor (Apollo-9000A) was used to monitor the qCON and qNOX values of patients during the painless gastrointestinal endoscopy. The changes in 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.

Conditions

Depth of Anesthesia; Nociception; Painless Gastrointestinal Endoscopy

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

EEG monitoring

Intervention Type: 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

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.

EEG monitoring

Intervention Type: 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.

Interventions

EEG monitoring

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Aged 18-60 years old;

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

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

4. Individuals scheduled for elective gastroscopy and colonoscopy examinations;

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

Exclusion Criteria

1. Pregnant or breastfeeding women;

2. Individuals with allergies to sedatives/anesthetic drugs or other severe anesthetic risks;

3. Patients with chronic preoperative pain or a history of substance abuse;

4. Individuals with severe neurological diseases, such as stroke, hemiplegia, seizures, epilepsy, etc.;

5. Patients with clearly difficult airways, such as those with limited mouth opening, neck or jaw mobility restrictions, rheumatoid arthritis, or temporomandibular joint disorders;

6. Individuals with respiratory diseases, such as bronchitis, asthma, chronic obstructive pulmonary disease, or acute respiratory infections, which may lead to increased airway sensitivity;

7. Patients with chronic pharyngitis, laryngitis, laryngeal edema, or recurrent laryngeal nerve paralysis that may affect normal throat function;

8. Individuals with esophagitis, esophageal strictures, or esophageal motility disorders that may cause difficulty swallowing or reflux;

9. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Min Su

OTHER

Sponsor Role: lead

Responsible Party

Min Su

Professor of Anesthesiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Su Min

Role: STUDY_DIRECTOR

First Affiliated Hospital of Chongqing Medical University

Locations

China,Chongqing The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qin Liu

Role: CONTACT

17713733719@163.com

17713733719

Su Min

Role: CONTACT

Facility Contacts

Qin Liu, MD

Role: primary

17713733719@163.com

17713733719

Other Identifiers

2024-239-01

Identifier Type: -

Identifier Source: org_study_id