The Effects of Remimazolam on the Incidence of Severe Hypoxia During Sedated Hysteroscopy for Assisted Reproduction in Overweight or Obese Patients: a Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- The incidence of severe hypoxia
研究概览
简要总结
Hypoxia is a common adverse event during sedated hysteroscopy for assisted reproduction, and it is more likely to occur in overweight or obese patients. In sedated gastroscopy, the incidence of hypoxia with remimazolam is lower than that with propofol. The present study is a single-center, randomized, single-blind, controlled clinical trial. Overweight or obese patients undergoing sedated hysteroscopy for diagnosis and treatment, with ASA grade I or II, were selected as subjects and randomly divided into an experimental group and a control group, with 300 subjects in each group. Sedation induction and maintenance are performed using remimazolam or propofol combined with remifentanil, respectively, to compare the incidence of severe hypoxia during surgery between the two groups of patients.
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
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 20 and 50 years.
- •Patients undergoing sedated hysteroscopy for assisted reproduction.
- •ASA classification I-II.
- •BMI ≥ 23 kg/㎡.
- •Patients who have signed an informed consent form.
排除标准
- •SpO2 < 95% in patients inhaling air upon entering the room.
- •Diagnosed with chronic obstructive pulmonary disease (COPD) or currently suffering from other acute and chronic lung diseases requiring long-term or intermittent oxygen therapy.
- •Patients with a history of mental and neurological disorders: such as depression, severe central nervous system depression, Parkinson's disease, basal ganglia disease, schizophrenia, epilepsy, Alzheimer's disease, myasthenia gravis, etc.
- •Patients with severe liver dysfunction.
- •Patients with severe renal insufficiency (requiring dialysis before surgery).
- •Severe heart failure (METS < 4).
- •History of drug abuse and/or alcohol abuse within the 2 years preceding the screening period (consuming more than three times the standard alcoholic beverages daily, approximately 10g of alcohol, or equivalent to 50g of Chinese alcohol).
- •Allergies or contraindications to benzodiazepines, flumazenil, opiates and their rescue medications, propofol, eggs, or soy products.
- •Breastfeeding women.
- •Patients whom investigator believe are unsuitable for participating in this trial.
研究组 & 干预措施
Remimazolam
In this group, participants are sedated with remimazolam and remifentanil.
干预措施: remimazolam (Drug)
propofol
In this group, participants are sedated with propofol and remifentanil.
干预措施: Propofol (Drug)
结局指标
主要结局
The incidence of severe hypoxia
时间窗: people will be followed for the duration of hospital stay,an expected average about 2 hours
SpO2\<75% or 75%≤ SpO2\<90% for≥60s
次要结局
- The incidence of other adverse events(people will be followed for the duration of hospital stay,an expected average about 2 hours)
- The incidence of hypoxia(people will be followed for the duration of hospital stay,an expected average about 2 hours)
- The incidence of sub-clinical respiratory depression(people will be followed for the duration of hospital stay,an expected average about 2 hours)
研究者
diansan su
vice chair of the department of anesthesiology
RenJi Hospital