Painless AbortionAAS-PANCT07132151
Reinforcement Learned Automated Anesthesia Systems During Painless Abortion
A study testing General Anesthesia in people with Painless Abortion and Artificial Intelligence (AI), run by Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd. at 8 sites in China.
Trial summary
This study compares the automated anesthesia systems for painless abortion (AAS-PA) with traditional anesthesia in painless abortions. It assesses intraoperative indicators (hypoxemia, injection pain, hypotension, hemodynamics, respiratory depression) and postoperative outcomes (nausea, dizziness, recovery time… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Painless Abortion, Artificial Intelligence (AI), Ciprofol
- What is being tested?
- General Anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 8 sitesChina
- Study dates
- 8 Sep 2025to 8 Nov 2027
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18-45 years
- ASA status Ⅰ to Ⅱ
- Diagnosed with early intrauterine pregnancy
- Body mass index (BMI) between 18 to 28 kg/m2
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
- History of substance or alcohol abuse
- ASA class III or higher
- Participation in any other drug clinical trial within the past 3 months
- Long-term use of sedative or analgesic medications
- History of neurological disorders and convulsions
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites
Sichuan Provincial People's Hospital
Chengdu, Sichuan
The First Affiliated Hospital of Army Medical University
Chongqing
The People's Hospital of Yubei District of Chongqing city
Chongqing
Fujian Provincial Hospital
Fuzhou, Fujian
Jinjiang Municipal Hospital (Shanghai Sixth People's Hospital Fujian)
Jinjiang, Fujian
Shishi Hospital
Quanzhou, Fujian
Peking University Shenzhen Hospital
Shenzhen, Guangdong
Zhengzhou Central Hospital Affiliated to Zhengzhou University
Zhengzhou, Henan
About this study
Official title: Automated Anesthesia Systems for Painless Abortion (AAS-PA): a Multi-center, Randomized Controlled Trial
This study compares the automated anesthesia systems for painless abortion (AAS-PA) with traditional anesthesia in painless abortions. It assesses intraoperative indicators (hypoxemia, injection pain, hypotension, hemodynamics, respiratory depression) and postoperative outcomes (nausea, dizziness, recovery time, satisfaction). The AAS-PA group uses AI-adjusted intravenous ciprofol based on real-time vital signs and sedation depth; the traditional group relies on manual anesthesia. The goal is to verify if AAS-PA safely manages sedation, meets painless standards, reduces adverse events, and improves experience, aiding optimized automated protocols.
- Conditions
- Painless Abortion, Artificial Intelligence (AI), Ciprofol
- Being tested
- AI Controlled General Anesthesia, General Anesthesia
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 painless abortion, anesthesia will be induced using ciprofol, and controlled by an AI model.
General AnesthesiaProcedure 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 | Experimental | In the control group, anesthesia will be induced by experienced anesthesiologists. Receives: Procedure: General Anesthesia |
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
Duration of colonoscopy
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
Ciprofol related adverse reactions
Included sinus bradycardia, dizziness
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start8 Sep 2025 (estimated)
- Primary completion8 Oct 2025 (estimated)
- Study completion8 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painless AbortionStudies 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
- 167 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
- Fujian Provincial Hospital, Shishi Hospital, Sichuan Provincial People's Hospital, First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University, The People's Hospital of Yubei District of Chongqing city, Peking University Shenzhen Hospital, People's Hospital of Zhengzhou University, Jinjiang Municipal Hospital (Shanghai Sixth People's Hospital Fujian)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132151
- Sponsor's protocol ID
- SZUS2025002
- Acronym
- AAS-PA
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Anesthesia Systems for Painless Abortion (AAS-PA): a Multi-center, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07132151
- Acronym / sponsor ID
- AAS-PA / SZUS2025002
- Conditions
- Painless Abortion, Artificial Intelligence (AI), Ciprofol
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 167 participants (estimated)
- Lead sponsor
- Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Fujian Provincial Hospital, Shishi Hospital, Sichuan Provincial People's Hospital, First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University, The People's Hospital of Yubei District of Chongqing city, Peking University Shenzhen Hospital, People's Hospital of Zhengzhou University, Jinjiang Municipal Hospital (Shanghai Sixth People's Hospital Fujian)
- Study start
- 8 Sep 2025 (estimated)
- Primary completion
- 8 Oct 2025 (estimated)
- Study completion
- 8 Nov 2027 (estimated)
- First posted
- 20 Aug 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.
This study compares the automated anesthesia systems for painless abortion (AAS-PA) with traditional anesthesia in painless abortions. It assesses intraoperative indicators (hypoxemia, injection pain, hypotension, hemodynamics, respiratory depression) and postoperative outcomes (nausea, dizziness, recovery time, satisfaction). The AAS-PA group uses AI-adjusted intravenous ciprofol based on real-time vital signs and sedation depth; the traditional group relies on manual anesthesia. The goal is to verify if AAS-PA safely manages sedation, meets painless standards, reduces adverse events, and improves experience, aiding optimized automated protocols.
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 | Experimental | Procedure: General AnesthesiaIn the control group, anesthesia will be induced by experienced anesthesiologists. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18-45 years
- ASA status Ⅰ to Ⅱ
- Diagnosed with early intrauterine pregnancy
- Body mass index (BMI) between 18 to 28 kg/m2
Key exclusion criteria (8 listed)
- History of cardiac, hepatic, renal, or metabolic disorders (e.g., diabetes, hypertension, sleep apnea)
- Known allergy to opioids or ciprofloxacin components
- Cachexia
- History of substance or alcohol abuse
- ASA class III or higher
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 painless abortion, anesthesia will be induced using ciprofol, and controlled by an AI model. | Procedure or surgery | Test group |
| General AnesthesiaAnesthesia 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
Duration of colonoscopy
Time frame: During procedure
Lowest value of blood oxygen saturation
Time frame: During procedure
Induction and maintenance doses of anesthesia
Time frame: During procedure
Ciprofol related adverse reactions
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
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 20 Aug 2025.
- Individual participant dataSharing planned: Undecided
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.
8 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 in people with Painless Abortion and Artificial Intelligence (AI), run by Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd. at 8 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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 20 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 8 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 Qingwang Lu (+86 13675930836, mxbj-2008@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?
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 20 Aug 2025.