The Efficacy of Remimazolam on Incidence of Hypoxia During Sedated Transvaginal Oocyte Retrieval: A Multicenter Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Incidence of Hypoxia
研究概览
简要总结
Hypoxia is the most common adverse reaction during sedation outside the operating room.Exploring novel drug combinations to reduce the incidence of hypoxia during sedation in patients undergoing transvaginal oocyte retrieval procedures enhances patient safety and lowers perioperative adverse event rates. This multicenter, prospective, randomized, controlled clinical study will compare the hypoxia incidence rate of the remimazolam-alfentanil combination against the commonly used propofol-alfentanil combination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 18 to 50 years planning to undergo painless oocyte retrieval
- •Subjects classified as American Society of Anesthesiologists (ASA) physical status I-II
排除标准
- •Subjects with contraindications to general anesthesia, acute or severe cardiovascular disease history, acute upper respiratory infection, chronic obstructive pulmonary disease (COPD), asthma attacks, or uncontrolled hypertension
- •Subjects with alcohol abuse
- •Subjects with severe hepatic or renal insufficiency, severe cardiovascular disease, or psychiatric disorder history
- •Subjects with hearing impairment preventing communication
- •Subjects with a history of long-term sedative or opioid use, or allergies to benzodiazepines, flumazenil, opioids and their antidotes, propofol, eggs, or soy products
- •Subjects with SpO2 < 95% while breathing room air after entering the room
研究组 & 干预措施
propofol-alfentanil
Sedation using remimazolam-alfentanil
干预措施: propofol-alfentanil (Drug)
remimazolam-alfentanil
Sedation using remimazolam-alfentanil
干预措施: remimazolam-alfentanil combination (Drug)
结局指标
主要结局
Incidence of Hypoxia
时间窗: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
SpO₂ between 75% and 89% with duration \<60 seconds
次要结局
- Incidence of severe hypoxia(Patients will be followed for the duration of hospital stay, an expected average about 2 hours)
- Incidence of subclinical respiratory depression(Patients will be followed for the duration of hospital stay, an expected average about 2 hours)
- Proportion of hypoxic correction measures(Patients will be followed for the duration of hospital stay, an expected average about 2 hours)
研究者
Diansan Su
Director of Anesthesiology
Zhejiang University