Automated Anesthesia Systems for Painless Abortion (AAS-PA): a Multi-center, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 167
- 试验地点
- 8
- 主要终点
- Incidence of Hypoxemia
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •History of cardiac, hepatic, renal, or metabolic disorders (e.g., diabetes, hypertension, sleep apnea)
- •Known allergy to opioids or ciprofloxacin components
- •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
结局指标
主要结局
Incidence of Hypoxemia
时间窗: During procedure
Hypoxemia is defined as blood oxygen saturation below 92% at any time.
次要结局
- Ciprofol related adverse reactions(During procedure)
- Induction time(During procedure)
- Complete recovery time(During procedure)
- Area under curve of hypoxemia(During procedure)
- Duration of colonoscopy(During procedure)
- Lowest value of blood oxygen saturation(During procedure)
- Incidence of hypotension(During procedure)
- Counts of body movement(During procedure)
- Induction and maintenance doses of anesthesia(During procedure)
- Dose of norepinephrine(During procedure)