Reinforcement Learned Automatic Anesthesia System During Painless Gastrointestinal Endoscopy (AAS-GE)

Shenzhen United Scheme Technology

Status: Enrolling

Conditions: Anesthesia Induction

Treatments: Procedure: AI Controlled General Anesthesia; Procedure: General Anesthesia (GA)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06857344

SZUS2025001

Details and patient eligibility

About

The goal of this clinical trial is to compare the performance difference between trained model and clinical professionals in anesthesia control during gastrointestinal endoscopy. The participants would include adults aged between 18-65 years old with ASA scores I-II. The main questions it aims to answer are:

• Can AI model successfully and safely perform anesthesia during gastrointestinal endoscopy?
• Researchers hypothesis that anesthesia performed by professionals is not inferior to those performed by AI model.

The researchers will compare the results of the AI group with the traditional group to see if both groups have similar success rates in performing anesthesia.

Participants will fast for 8 hours before the procedure, and drinking water will be prohibited for 2 hours after taking the intestinal purgatives.

Enrollment: 164 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiologists (ASA) physical status class I-II
• Expected operation duration less than 1 hour

Exclusion criteria

• History of cardiac, hepatic, renal, or metabolic disorders (e.g., diabetes, hypertension, sleep apnea)
• Known allergy to opioids or ciprofloxacin components
• Cachexia
• Hypothermia; history of narcotic abuse; chronic alcoholism; obesity (BMI >30); patients with apnea
• Current pregnancy or lactation
• History of substance abuse or alcohol dependence
• Participation in any other drug clinical trial within the past 3 months
• Obesity (BMI >30 kg/m²)
• Procedure termination due to gastric retention or inadequate bowel preparation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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164 participants in 2 patient groups

Test group

Experimental group

Description:

In the test group, participants will receive anesthesia via an AI model.

Treatment:

Procedure: AI Controlled General Anesthesia

Control group

Active Comparator group

Description:

In the control group, anesthesia will be induce by experienced anesthesiologists

Treatment:

Procedure: General Anesthesia (GA)