About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
American Society of Anesthesiologists (ASA) physical status class I-II
Expected operation duration less than 1 hour
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
AI Controlled General Anesthesia
Procedure/SurgeryDuring gastrointestinal endoscopy, anesthesia will be induced using ciprofol, and controlled by an AI model.
General Anesthesia (GA)
Procedure/SurgeryAnesthesia will be induced using ciprofol, and controlled by experienced anesthesiologists.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of hypoxemia
Hypoxemia is defined as blood oxygen saturation below 92% at any time.
Secondary outcomes
Area under curve of hypoxemia
The area where SpO2 is below 92%.
Lowest value of blood oxygen saturation
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.
Induction time
The time interval from the start of drug administration to the first BIS ≤ 1.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.
Lead sponsor
Zhengzhou Central Hospital
Collaborator
Xinzheng Public People's Hospital
Collaborator
Henan Provincial People's Hospital
Collaborator
Anxi County Hospital
Collaborator
Jinjiang Municipal Hospital, Shanghai Sixth People's Hospital Fujian Campus
Collaborator