Painless Abortion, Artificial Intelligence (AI), Ciprofol
Conditions
Brief 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.
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.
Sponsors
Fujian Provincial Hospital
Shishi Hospital
Sichuan Provincial People's Hospital
The First Affiliated Hospital of Army 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)
Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Hypoxemia | During procedure | Hypoxemia is defined as blood oxygen saturation below 92% at any time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of colonoscopy | During procedure | — |
| Lowest value of blood oxygen saturation | During procedure | — |
| Induction and maintenance doses of anesthesia | 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. |
| Ciprofol related adverse reactions | During procedure | Included sinus bradycardia, dizziness |
| Area under curve of hypoxemia | During procedure | The area where SpO2 is below 92%. |
| Complete recovery time | During procedure | Time interval from cessation of anesthetic agents to BIS \> 80. |
| Incidence of hypotension | During procedure | Systolic blood pressure \< 90 mmHg or a 30% decrease from baseline lasting longer than 2 minutes. |
| Counts of body movement | During procedure | — |
| Dose of norepinephrine | During procedure | — |
| Induction time | During procedure | The time interval from the start of drug administration to the first BIS ≤ 1. |
Countries
China
Contacts
Primary ContactQingwang Lu
Outcome results
None listed