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Not yet recruitingNCT07132151AAS-PAUpdated Aug 20, 2025

Reinforcement Learned Automated Anesthesia Systems During Painless Abortion

An interventional study of AI Controlled General Anesthesia and General Anesthesia in Painless Abortion, Artificial Intelligence (AI) and Ciprofol, sponsored by Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.. Not yet recruiting at 8 sites in China. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-20.

Sponsored by Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2025, 11 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
167
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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, 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.

02

Conditions studied

  • Painless Abortion
  • Artificial Intelligence (AI)
  • Ciprofol
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
167 participants (estimated)

Study arms

  • Experimental
    Test group

    In the test group, participants will receive anesthesia via an AI model.

    Procedure: AI Controlled General Anesthesia

  • Experimental
    Control group

    In the control group, anesthesia will be induced by experienced anesthesiologists.

    Procedure: General Anesthesia

Interventions

  • ProcedureAI Controlled General Anesthesia

    During painless abortion, anesthesia will be induced using ciprofol, and controlled by an AI model.

  • ProcedureGeneral Anesthesia

    Anesthesia will be induced using ciprofol, and controlled by experienced anesthesiologists.

06

What researchers measure

Primary outcomes

  1. Incidence of Hypoxemia

    Hypoxemia is defined as blood oxygen saturation below 92% at any time.

    Time frame: During procedure

Secondary outcomes

  1. Area under curve of hypoxemia

    The area where SpO2 is below 92%.

    Time frame: During procedure

  2. Duration of colonoscopy

    Time frame: During procedure

  3. Lowest value of blood oxygen saturation

    Time frame: During procedure

  4. 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

  5. Ciprofol related adverse reactions

    Included sinus bradycardia, dizziness

    Time frame: During procedure

  6. Induction time

    The time interval from the start of drug administration to the first BIS ≤ 1.

    Time frame: During procedure

  7. Complete recovery time

    Time interval from cessation of anesthetic agents to BIS \> 80.

    Time frame: During procedure

  8. Incidence of hypotension

    Systolic blood pressure \< 90 mmHg or a 30% decrease from baseline lasting longer than 2 minutes.

    Time frame: During procedure

  9. Counts of body movement

    Time frame: During procedure

  10. Dose of norepinephrine

    Time frame: During procedure

07

Study locations

8 sites
  • Fujian Provincial Hospital
    Fuzhou, Fujian, China
  • Jinjiang Municipal Hospital (Shanghai Sixth People's Hospital Fujian)
    Jinjiang, Fujian, China
  • Shishi Hospital
    Quanzhou, Fujian, China
  • Peking University Shenzhen Hospital
    Shenzhen, Guangdong, China
  • Zhengzhou Central Hospital Affiliated to Zhengzhou University
    Zhengzhou, Henan, China
  • Sichuan Provincial People's Hospital
    Chengdu, Sichuan, China
  • The First Affiliated Hospital of Army Medical University
    Chongqing, China
  • The People's Hospital of Yubei District of Chongqing city
    Chongqing, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07132151
Lead sponsor
Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.
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
First posted
Aug 20, 2025
Start date
Sep 8, 2025 (estimated)
Primary completion
Oct 8, 2025 (estimated)
Completion
Nov 8, 2027 (estimated)
Last update
Aug 20, 2025

Study contacts

Qingwang Lu
Contact
mxbj-2008@163.com
+86 13675930836

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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