Health TrialsbyHealthPanel

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

ConditionsDepth of AnesthesiaNociceptionPainless Gastrointestinal Endoscopy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorMin Su

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18-60 years old;

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

Body mass index (BMI): 18-30 kg/m²;

Individuals scheduled for elective gastroscopy and colonoscopy examinations;

Disqualifiers

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.;

Trial population

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

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: Gastroscopy group1 intervention
Group B: Colonoscopy group1 intervention

Trial outcomes

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)

Time frame
during the procedure

Secondary outcomes

1

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

The Values of qCON 、 qNOX、MAP、HR、SPO2 and MOAA/S at different time points during gastroscopy and enteroscopy ① Time points for gastroscopy: Baseline value (T0), Loss of consciousness (T1), Before insertion of the gastroscope (T2), Passage of the gastroscope through the pharynx (T3), After insertion of the gastroscope (T4), Withdrawal of the gastroscope to the pharynx (T5), Examination completion (T6), Admission to recovery room (T7), Awakening (T8), Discharge from recovery room (T9). ② Time points for colonoscopy: Baseline value (T0), Loss of consciousness (T1), Before insertion of the colonoscope (T2), After insertion of the colonoscope into the anus (S3), Descending colon (T4), Splenic flexure (T5), Hepatic flexure (T6), Examination completion (T7), Admission to recovery room (T8), Awakening (T9), Discharge from recovery room (T10).

Time frame
during the procedure
2

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

During gastroscopy and colonoscopy , the values of qCON 、 qNOX、MAP、HR、SPO2 are recorded when coughing, body movement, polypectomy, or biopsy occur.

Time frame
during the procedure
3

Adverse event

Adverse events during gastroscopy and enteroscopy were recorded, including hypotension, hypertension, tachycardia, bradycardia, respiratory depression, hypoxemia, cough, body movement, nausea, vomiting, hiccup, injection pain, abdominal pain, abdominal distension, reflux aspiration.

Time frame
during the procedure
4

Adverse events and complications after examination

Bleeding, dizziness, blurred vision, nausea, vomiting, abdominal pain, abdominal distension were followed up 24h after the examination

Time frame
24 hours after procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Min Su

Lead sponsor

First Affiliated Hospital of Chongqing Medical University

Sponsor institution

Source ClinicalTrials.gov
Apply now