Anesthesia Induction
Conditions
Brief summary
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.
Interventions
PROCEDUREAI Controlled General Anesthesia
During gastrointestinal endoscopy, anesthesia will be induced using ciprofol, and controlled by an AI model.
PROCEDUREGeneral Anesthesia (GA)
Anesthesia will be induced using ciprofol, and controlled by experienced anesthesiologists.
Sponsors
Zhengzhou Central Hospital
Xinzheng Public People's Hospital
Henan Provincial People's Hospital
Anxi County Hospital
Jinjiang Municipal Hospital, Shanghai Sixth People's Hospital Fujian Campus
Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hypoxemia | During procedure | Hypoxemia is defined as blood oxygen saturation below 92% at any time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lowest value of blood oxygen saturation | During procedure | — |
| Induction and maintenance doses of anesthesia | During procedure | 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 | During procedure | The time interval from the start of drug administration to the first BIS ≤ 1. |
| Complete recovery time | During procedure | Time interval from cessation of anesthetic agents to BIS \> 80. |
| Area under curve of hypoxemia | During procedure | The area where SpO2 is below 92%. |
| Counts of body movement | During procedure | — |
| Dose of norepinephrine | During procedure | — |
| Duration of colonoscopy | During procedure | — |
| Ciprofol related adverse reactions | During procedure | Included sinus bradycardia, dizziness |
| Incidence of hypotension | During procedure | systolic blood pressure \< 90 mmHg or a 30% decrease from baseline lasting longer than 2 minutes |
Countries
China
Contacts
Primary ContactDr. Chu
Outcome results
None listed