AI Controlled General Anesthesia
ProcedureDuring painless abortion, anesthesia will be induced using ciprofol, and controlled by an AI model.
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NCT Number: NCT07132151
Reinforcement Learned Automated Anesthesia Systems During Painless Abortion
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.
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Trial opening soon.
Get NotifiedKey information
Age range
18 year–45 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
Fujian Provincial Hospital, Fuzhou, Fujian, China
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Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
- 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
Treatment and study plan
General Anesthesia
ProcedureAnesthesia will be induced using ciprofol, and controlled by experienced anesthesiologists.
Primary outcomes
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Incidence of Hypoxemia
Time frame: During procedure
Hypoxemia is defined as blood oxygen saturation below 92% at any time.
Secondary outcomes
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Area under curve of hypoxemia
Time frame: During procedure
The area where SpO2 is below 92%.
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Duration of colonoscopy
Time frame: During procedure
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Lowest value of blood oxygen saturation
Time frame: During procedure
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Induction and maintenance doses of anesthesia
Time frame: During procedure
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.
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Ciprofol related adverse reactions
Time frame: During procedure
Included sinus bradycardia, dizziness
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Induction time
Time frame: During procedure
The time interval from the start of drug administration to the first BIS ≤ 1.
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Complete recovery time
Time frame: During procedure
Time interval from cessation of anesthetic agents to BIS > 80.
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Incidence of hypotension
Time frame: During procedure
Systolic blood pressure < 90 mmHg or a 30% decrease from baseline lasting longer than 2 minutes.
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Counts of body movement
Time frame: During procedure
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Dose of norepinephrine
Time frame: During procedure
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.
Industry
Collaborators
- First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University
- Fujian Provincial Hospital
- Jinjiang Municipal Hospital (Shanghai Sixth People's Hospital Fujian)
- Peking University Shenzhen Hospital
- People's Hospital of Zhengzhou University
- Shishi Hospital
- Sichuan Provincial People's Hospital
- The People's Hospital of Yubei District of Chongqing city
Registry information
Official study title
Automated Anesthesia Systems for Painless Abortion (AAS-PA): a Multi-center, Randomized Controlled Trial
Acronym: AAS-PA
Important dates
- Study start
- 2025
- Primary completion
- 2025
- Study completion
- 2027
- First posted
- Aug 20, 2025
- Registry last updated
- Aug 20, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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