A Multicenter, Randomized, Single-blind, Parallel Controlled Clinical Study on the Efficacy and Safety of Remimazolam Tosylate for Sedation in Gastroscopy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,800
- 试验地点
- 5
- 主要终点
- The success rate of remazolam tosylate for sedation in gastroscopy diagnosis and treatment
研究概览
简要总结
Propofol is the most commonly used intravenous anesthetic for painless gastroscopy, but propofol significantly inhibits the respiratory and circulatory systems. Therefore, the incidence of intraoperative hypoxemia and hypotension is high. Remazolam tosylate is an ultra-short-acting benzodiazepine drug, which has a mild inhibitory effect on the respiratory and circulatory systems and has anterograde amnesia. These advantages make remazolam tosylate very likely to replace propofol in painless gastroscopic anesthesia.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18≤age≤60 years old, no gender limit; 2) Patients receiving routine gastroscopy diagnosis and treatment; 3) ASA score is I or II; 4) 18 kg/m2<BMI<28kg/m2； 5) It is estimated that the operation time of gastroscope will not exceed 30 minutes; 6) Clearly understand, voluntarily participate in the research, and be signed and informed consent.
排除标准
- •Need to perform complicated endoscopic diagnosis and treatment techniques (such as cholangiopancreatography Surgery, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosa Stripping, oral endoscopic muscle dissection, etc.);
- •Patients who intend to undergo tracheal intubation;
- •It is judged to be difficult to manage the respiratory tract (modified Mallampati score is IV)patient;
- •Anemia or thrombocytopenia,( Hb<90g/L, PLT<80×109/L);
- •Diagnosed lung diseases (asthma, bronchitis, COPD, Pulmonary bullae,pulmonary embolism, pulmonary edema, lung cancer);
- •Liver and kidney disease;( AST and/or ALT≥2.5×ULN,TBIL≥1.5×ULN, blood creatinine is greater than the upper limit of normal);
- •There is a history of drug and/or alcohol abuse within 2 years before the beginning of the screening period.The average daily alcohol consumption exceeds 2 units of alcohol (1 unit = 360 mL beer Liquor or 45 mL liquor with 40% alcohol content or 150 mL grapes liqueur);
- •Hypertensive patients whose blood pressure has not been satisfactorily controlled by antihypertensive drugs(Sitting systolic blood pressure ≥160 mmHg during screening period, and/or diastolic pressure during screening period Pressure ≥100 mmHg);
- •Sitting systolic blood pressure ≤90 mmHg during the screening period;
- •Women who are pregnant or breastfeeding;
- •Benzodiazepines, opioids, propofol, lidoca Those who are allergic or contraindicated due to their drug components;
- •Participated in other drug clinical trials as subjects in the past 3 months;
- •The investigator believes that it is not appropriate to participate in this trial;
- •A well-diagnosed heart disease (heart failure, angina pectoris, myocardial infarction, heart rhythmabnormalities etc.).
研究组 & 干预措施
Control group
Propofol（1.5mg/kg）
干预措施: Propofol (Drug)
Test group 1（Remimazolam tosylate 0.15mg/kg）
Remimazolam tosylate 0.15mg/kg
干预措施: Remimazolam tosylate (Drug)
Test group 2（Remimazolam tosylate 0.2mg/kg）
Remimazolam tosylate 0.2mg/kg
干预措施: Remimazolam tosylate (Drug)
结局指标
主要结局
The success rate of remazolam tosylate for sedation in gastroscopy diagnosis and treatment
时间窗: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
1) Complete the entire process of gastroscopy; 2) No sedative remedy is given; 3) After the initial dose of the test drug is administered, additional administration ≤ 2 times within any 5-minute period; 4) The initial dose of propofol After the end, within any 5-minute period of additional administration ≤ 2 times, it is recorded as propofol (control group) successfully sedated
次要结局
- Sedation induction time(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)
- Doctor satisfaction and patient satisfaction(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)
- Incidence of drug injection pain(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)
- The time it takes for the patient to wake up and leave the hospital if the Sedation/Anaesthesia Discharge Rating Scale score exceeds 9 points;(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)
- The incidence of hypoxia during sedation(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)
- Other adverse events assessed by the World SIVA adverse sedation event reporting tool(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)
- Sedation recovery time(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)
研究者
diansan su
Vice Chair of the Department of Anesthesiology
RenJi Hospital