Anesthesia InductionAAS-GENCT06857344
Reinforcement Learned Automatic Anesthesia System During Painless Gastrointestinal Endoscopy
A study testing General Anesthesia (GA) in people with Anesthesia Induction, run by Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd. at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia Induction
- What is being tested?
- General Anesthesia (GA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 5 sitesChina
- Study dates
- 1 May 2025to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status class I-II
- Expected operation duration less than 1 hour
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Anxi County Hospital
Anxi, Fujian
- Recruiting
Jinjiang Municipal Hospital, Shanghai Sixth People's Hospital Fujian Campus
Jinjiang, Fujian
- Recruiting
Xinzheng Public People's Hospital
Xinzheng, Henan
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan
- Recruiting
Zhengzhou Central Hospital
Zhengzhou, Henan
About this study
Official title: Automated Anesthesia System-Gastrointestinal Endoscopy (AAS-GE): a Reinforcement Learning Based Control for Anesthesia During Gastrointestinal Endoscopy
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.
Read more
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.
- Conditions
- Anesthesia Induction
- Being tested
- AI Controlled General Anesthesia, General Anesthesia (GA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI Controlled General AnesthesiaProcedure or surgery
During gastrointestinal endoscopy, anesthesia will be induced using ciprofol, and controlled by an AI model.
General Anesthesia (GA)Procedure or surgery
Anesthesia will be induced using ciprofol, and controlled by experienced anesthesiologists.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | In the test group, participants will receive anesthesia via an AI model. Receives: Procedure: AI Controlled General Anesthesia |
| Control group | Active comparator | In the control group, anesthesia will be induce by experienced anesthesiologists Receives: Procedure: General Anesthesia (GA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypoxemia
Hypoxemia is defined as blood oxygen saturation below 92% at any time.
Measured: During procedure
Secondary outcomes (10)
Area under curve of hypoxemia
The area where SpO2 is below 92%.
Measured: During procedure
Lowest value of blood oxygen saturation
Measured: 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.
Measured: During procedure
Induction time
The time interval from the start of drug administration to the first BIS ≤ 1.
Measured: During procedure
Complete recovery time
Time interval from cessation of anesthetic agents to BIS > 80.
Measured: During procedure
Incidence of hypotension
systolic blood pressure < 90 mmHg or a 30% decrease from baseline lasting longer than 2 minutes
Measured: During procedure
Counts of body movement
Measured: During procedure
Dose of norepinephrine
Measured: During procedure
Duration of colonoscopy
Measured: During procedure
Ciprofol related adverse reactions
Included sinus bradycardia, dizziness
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start1 May 2025
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia InductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857344
- Sponsor's protocol ID
- SZUS2025001
- Acronym
- AAS-GE
- Status last verified
- Aug 2025
- First submitted
- 26 Feb 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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;9(1):539. doi: 10.1038/s41746-026-02657-8.
PubMed 42056274
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Anesthesia System-Gastrointestinal Endoscopy (AAS-GE): a Reinforcement Learning Based Control for Anesthesia During Gastrointestinal Endoscopy
- ClinicalTrials.gov ID
- NCT06857344
- Acronym / sponsor ID
- AAS-GE / SZUS2025001
- Conditions
- Anesthesia Induction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- 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
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Procedure: AI Controlled General AnesthesiaIn the test group, participants will receive anesthesia via an AI model. |
| Control group | Active comparator | Procedure: General Anesthesia (GA)In the control group, anesthesia will be induce by experienced anesthesiologists |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status class I-II
- Expected operation duration less than 1 hour
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI Controlled General AnesthesiaDuring gastrointestinal endoscopy, anesthesia will be induced using ciprofol, and controlled by an AI model. | Procedure or surgery | Test group |
| General Anesthesia (GA)Anesthesia will be induced using ciprofol, and controlled by experienced anesthesiologists. | Procedure or surgery | Control group |
Primary outcome
Incidence of hypoxemia
Time frame: During procedure
Hypoxemia is defined as blood oxygen saturation below 92% at any time.
10 secondary outcomes
Area under curve of hypoxemia
Time frame: During procedure
Lowest value of blood oxygen saturation
Time frame: During procedure
Induction and maintenance doses of anesthesia
Time frame: During procedure
Induction time
Time frame: During procedure
Complete recovery time
Time frame: During procedure
Incidence of hypotension
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
Time frame: During procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Derived from this study: PubMed 42056274Bing 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;9(1):539. doi: 10.1038/s41746-026-02657-8.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General Anesthesia (GA) in people with Anesthesia Induction, run by Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd. at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Chu (+86 138 3810 0696, jimmynetchu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hypoxemia (time frame: During procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06857344, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025; AzTrials last refreshed its copy on 26 Oct 2026.