Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID06857344

Automated Anesthesia System-Gastrointestinal Endoscopy: Reinforcement Learning-Based Control for Anesthesia During Gastrointestinal Endoscopy

Led by Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd. · Updated on 2025-08-15

164

Participants Needed

5

Research Sites

4 weeks

Total Duration

On this page

Sponsors

B

Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.

Lead Sponsor

Z

Zhengzhou Central Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of an artificial intelligence (AI) system to control anesthesia during painless gastrointestinal endoscopy in adults aged 18 to 65 years with ASA physical status I-II. The study aims to compare the performance of the AI model against anesthesia provided by experienced clinical professionals to see if the AI is not inferior in safely managing anesthesia during the procedure. Participants will be randomly assigned to one of two groups: the test group receiving anesthesia controlled by the AI model using ciprofol, and the control group receiving anesthesia induced and maintained by anesthesiologists with ciprofol. Anesthesia induction and maintenance will be closely monitored during the gastrointestinal endoscopy. During the study, participants will fast for 8 hours before the procedure, with no drinking water allowed for 2 hours after taking intestinal purgatives. Researchers will assess outcomes including the incidence of hypoxemia, blood oxygen levels, anesthesia doses and timing, body movements, hypotension, norepinephrine use, procedure duration, and any adverse reactions related to ciprofol. The study includes double-blind monitoring and follows participants through the procedure to evaluate safety and effectiveness measures.

CONDITIONS

Brief Title

Reinforcement Learned Automatic Anesthesia System During Painless Gastrointestinal Endoscopy

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 65 years
  • American Society of Anesthesiologists (ASA) physical status class I or II
  • Expected procedure duration less than 1 hour
Not Eligible

You will not qualify if you...

  • History of cardiac, hepatic, renal, or metabolic disorders such as diabetes or hypertension
  • Known allergy to opioids or ciprofloxacin components
  • Cachexia
  • Hypothermia
  • History of narcotic abuse or chronic alcoholism
  • Obesity with BMI greater than 30 kg/m2
  • Patients with apnea
  • Current pregnancy or breastfeeding
  • History of substance abuse or alcohol dependence
  • Participation in another drug clinical trial within the past 3 months
  • Procedure termination due to gastric retention or inadequate bowel preparation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Less than 1 hour

Participants receive anesthesia induced by ciprofol during gastrointestinal endoscopy, controlled either by an AI model or experienced anesthesiologists.

1 procedure visit (in-person)

Trial Site Locations

Total: 5 locations

1

Anxi County Hospital

Anxi, Fujian, China

Actively Recruiting

2

Jinjiang Municipal Hospital, Shanghai Sixth People's Hospital Fujian Campus

Jinjiang, Fujian, China

Actively Recruiting

3

Xinzheng Public People's Hospital

Xinzheng, Henan, China

Actively Recruiting

4

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Actively Recruiting

5

Zhengzhou Central Hospital

Zhengzhou, Henan, China

Actively Recruiting

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Research Team

D

Dr. Chu

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Reinforcement learning based automated anesthesia system for gastrointestinal endoscopy with a multicenter randomized trial.

Hai-Long Bing, Yan Wang, Shi-Ying Li...

https://pubmed.ncbi.nlm.nih.gov/42056274