Remimazolam Versus Propofol, in Combination With Esketamine for Painless Abortion
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Time to loss of consciousness
研究概览
简要总结
The goal of this clinical trial is to compare the efficacy and safety of propofol vs. remimazolam in combine use of esketamine in women with early pregnancy undergoing painless abortion. The main questions it aims to answer are:
- whether remimazolam plus esketamine (R+E) has a better sedative and analgesic effectiveness than propofol plus esketamine (P+E).
- whether R+E has less adverse events than P+E.
Participants will be randomly allocated to two groups: R+E and P+E group.
- For those in group R+E: they will be administered with 0.3mg/kg remimazolam and 0.3mg/kg esketamine before the abortion surgery.
- For those in group P+E: they will be administered with 2mg/kg propofol and 0.3mg/kg esketamine before the abortion surgery.
We will compare R+E with P+E to see if the time to loss of conscious and time to recover from the sedation will be shorter and if there will be less severe adverse events in R+E.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •early intrauterine pregnancy less than 12 weeks confirmed by transabdominal ultrasound and blood HCG
- •the American Society of Anesthesiologists (ASA) physical status ranked I-II
- •competent to provide informed consent
排除标准
- •chronic pain
- •psychiatric disorders
- •liver or kidney failure
- •severe metabolic disorders
- •poor respiratory functions
- •cardiovascular diseases
研究组 & 干预措施
Remimazolam
Intravenous Remimazolam will be co-administrated with esketamine.
干预措施: Remimazolam (Drug)
Remimazolam
Intravenous Remimazolam will be co-administrated with esketamine.
干预措施: Esketamine (Drug)
Propofol
Intravenous Propofol will be co-administrated with esketamine.
干预措施: Propofol (Drug)
Propofol
Intravenous Propofol will be co-administrated with esketamine.
干预措施: Esketamine (Drug)
结局指标
主要结局
Time to loss of consciousness
时间窗: 5 - 30 minutes
The time from the study drug administration to loss of consciousness
次要结局
- Success rate of sedation(Intraoperative period, 30 minutes - 1.5 hours)
- Recovery time(Postoperative 30 minutes)
- Mean arterial pressure (MAP)(Intraoperative period, 30 minutes - 1.5 hours)
- Heart rate (HR)(Intraoperative period, 30 minutes - 1.5 hours)
- Adverse events(Intraoperative and post-operation, 30 minutes - 1.5 hours)
- Post-operative pain(Post-operation after fully awake, 30 minutes - 1 hour)
研究者
Li Na
Deputy Chief Physician
Maternal and Child Health Hospital of Hubei Province