An interventional study of AI Controlled General Anesthesia and General Anesthesia (GA) in Anesthesia Induction, sponsored by Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.. Recruiting at 5 sites in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-15.
Sponsored by Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd. · Not applicable, Interventional, and Treatment
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:
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.
Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd. is the lead sponsor of 6 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In the test group, participants will receive anesthesia via an AI model.
Procedure: AI Controlled General Anesthesia
In the control group, anesthesia will be induce by experienced anesthesiologists
Procedure: General Anesthesia (GA)
During gastrointestinal endoscopy, anesthesia will be induced using ciprofol, and controlled by an AI model.
Anesthesia will be induced using ciprofol, and controlled by experienced anesthesiologists.
Incidence of hypoxemia
Hypoxemia is defined as blood oxygen saturation below 92% at any time.
Time frame: During procedure
Area under curve of hypoxemia
The area where SpO2 is below 92%.
Time frame: During procedure
Lowest value of blood oxygen saturation
Time frame: 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.
Time frame: During procedure
Induction time
The time interval from the start of drug administration to the first BIS ≤ 1.
Time frame: During procedure
Complete recovery time
Time interval from cessation of anesthetic agents to BIS \> 80.
Time frame: During procedure
Incidence of hypotension
systolic blood pressure \< 90 mmHg or a 30% decrease from baseline lasting longer than 2 minutes
Time frame: During procedure
Counts of body movement
Time frame: During procedure
Dose of norepinephrine
Time frame: During procedure
Duration of colonoscopy
Time frame: During procedure
Ciprofol related adverse reactions
Included sinus bradycardia, dizziness
Time frame: During procedure
Plan to share: Undecided
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Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.