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

Automated Anesthesia System-Gastrointestinal Endoscopy (AAS-GE): a Reinforcement Learning Based Control for Anesthesia During Gastrointestinal Endoscopy

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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia Induction
• Intervention / Treatment: Procedure: AI Controlled General Anesthesia; Procedure: General Anesthesia (GA)

• Study Type: Interventional
• Enrollment (Estimated): 164
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Chu; Phone Number: +86 138 3810 0696; Email: jimmynetchu@163.com

Study Locations

• China
  • Fujian
    • Anxi, Fujian, China
      • Recruiting
      • Anxi County Hospital
    • Jinjiang, Fujian, China
      • Recruiting
      • Jinjiang Municipal Hospital, Shanghai Sixth People's Hospital Fujian Campus
  • Henan
    • Xinzheng, Henan, China
      • Recruiting
      • Xinzheng Public People's Hospital
    • Zhengzhou, Henan, China
      • Recruiting
      • Henan Provincial People's Hospital
    • Zhengzhou, Henan, China
      • Recruiting
      • Zhengzhou Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group; In the test group, participants will receive anesthesia via an AI model.	Procedure: AI Controlled General Anesthesia; During gastrointestinal endoscopy, anesthesia will be induced using ciprofol, and controlled by an AI model.
Active Comparator: Control group; In the control group, anesthesia will be induce by experienced anesthesiologists	Procedure: General Anesthesia (GA); Anesthesia will be induced using ciprofol, and controlled by experienced anesthesiologists.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hypoxemia	Hypoxemia is defined as blood oxygen saturation below 92% at any time.	During procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under curve of hypoxemia	The area where SpO2 is below 92%.	During procedure
Lowest value of blood oxygen saturation		During procedure
Induction and maintenance doses of anesthesia	Doses are recorded in mg/kg/h. The induction period is defined as the interval from the start of anesthesia to the first BIS value below 60. The maintenance period is defined as the interval from the first BIS value below 60 to the end of the drug infusion.	During procedure
Induction time	The time interval from the start of drug administration to the first BIS ≤ 1.	During procedure
Complete recovery time	Time interval from cessation of anesthetic agents to BIS > 80.	During procedure
Incidence of hypotension	systolic blood pressure < 90 mmHg or a 30% decrease from baseline lasting longer than 2 minutes	During procedure
Counts of body movement		During procedure
Dose of norepinephrine		During procedure
Duration of colonoscopy		During procedure
Ciprofol related adverse reactions	Included sinus bradycardia, dizziness	During procedure

Collaborators and Investigators

• Sponsor: Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.
• Collaborators: Henan Provincial People's Hospital; Zhengzhou Central Hospital; Anxi County Hospital; Jinjiang Municipal Hospital, Shanghai Sixth People's Hospital Fujian Campus; Xinzheng Public People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: February 26, 2025
• First Submitted That Met QC Criteria: February 26, 2025
• First Posted (Actual): March 4, 2025

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: SZUS2025001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No