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/42056274Actively Recruiting
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
B
Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.
Lead Sponsor
Z
Zhengzhou Central Hospital
Collaborating Sponsor
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
Reinforcement Learned Automatic Anesthesia System During Painless Gastrointestinal Endoscopy
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
D
Dr. Chu
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Hai-Long Bing, Yan Wang, Shi-Ying Li...
https://pubmed.ncbi.nlm.nih.gov/42056274