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| Name | Class |
|---|---|
| Zhengzhou Central Hospital | OTHER |
| Xinzheng Public People's Hospital | UNKNOWN |
| Henan Provincial People's Hospital | OTHER |
| Anxi County Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental | In the test group, participants will receive anesthesia via an AI model. |
|
| Control group | Active Comparator | In the control group, anesthesia will be induce by experienced anesthesiologists |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI Controlled General Anesthesia | Procedure | During gastrointestinal endoscopy, anesthesia will be induced using ciprofol, and controlled by an AI model. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hypoxemia | Hypoxemia is defined as blood oxygen saturation below 92% at any time. | During procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Area under curve of hypoxemia | The area where SpO2 is below 92%. | During procedure |
| Lowest value of blood oxygen saturation | During procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chu | Contact | +86 138 3810 0696 | jimmynetchu@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anxi County Hospital | Recruiting | Anxi | Fujian | China | ||
| Jinjiang Municipal Hospital, Shanghai Sixth People's Hospital Fujian Campus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42056274 | Derived | Bing HL, Wang Y, Li SY, Li YW, Wang QM, Li LM, Liu SQ, Hu ZH, Wang TW, Lu QW, Ran R, Wu Y, Xu SS, Li HJ, Huo J, Liu C, Hu AM, Xia ZY, Chu QJ. Reinforcement learning based automated anesthesia system for gastrointestinal endoscopy with a multicenter randomized trial. NPJ Digit Med. 2026 Apr 29. doi: 10.1038/s41746-026-02657-8. Online ahead of print. |
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| UNKNOWN |
| Jinjiang Municipal Hospital, Shanghai Sixth People's Hospital Fujian Campus | UNKNOWN |
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| General Anesthesia (GA) | Procedure | Anesthesia will be induced using ciprofol, and controlled by experienced anesthesiologists. |
|
| 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. | During procedure |
| Induction time | The time interval from the start of drug administration to the first BIS ≤ 1. | During procedure |
| Complete recovery time | Time interval from cessation of anesthetic agents to BIS > 80. | During procedure |
| Incidence of hypotension | systolic blood pressure < 90 mmHg or a 30% decrease from baseline lasting longer than 2 minutes | During procedure |
| Counts of body movement | During procedure |
| Dose of norepinephrine | During procedure |
| Duration of colonoscopy | During procedure |
| Ciprofol related adverse reactions | Included sinus bradycardia, dizziness | During procedure |
| Recruiting |
| Jinjiang |
| Fujian |
| China |
| Xinzheng Public People's Hospital | Recruiting | Xinzheng | Henan | China |
| Henan Provincial People's Hospital | Recruiting | Zhengzhou | Henan | China |
| Zhengzhou Central Hospital | Recruiting | Zhengzhou | Henan | China |
| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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