Reinforcement Learned Automated Anesthesia Systems During Painless Abortion

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorBoston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • AI Controlled General Anesthesia

    Procedure/Surgery

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

  • General Anesthesia

    Procedure/Surgery

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

Treatment groups

167 Participants
are divided into 2 treatment groups
Group A: Test groupExperimental treatment 1 intervention
Group B: Control groupExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.

Lead sponsor

Fujian Provincial Hospital

Collaborator

Shishi Hospital

Collaborator

Sichuan Provincial People's Hospital

Collaborator

First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University

Collaborator

The People's Hospital of Yubei District of Chongqing city

Collaborator

Peking University Shenzhen Hospital

Collaborator

People's Hospital of Zhengzhou University

Collaborator

Jinjiang Municipal Hospital (Shanghai Sixth People's Hospital Fujian)

Collaborator

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