Efficacy and Safety of Remimazolam Tosylate for Sedation in Gastroscopy

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Gastric Cancer; Sedation Complication; Propofol Adverse Reaction; Hypoxia

Treatments: Drug: Remimazolam tosylate; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT04727034

sudiansan1215

Details and patient eligibility

About

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.

Enrollment: 1,800 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1)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.

Exclusion criteria

1. 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.);
2. Patients who intend to undergo tracheal intubation;
3. It is judged to be difficult to manage the respiratory tract (modified Mallampati score is IV)patient;
4. Anemia or thrombocytopenia,( Hb<90g/L, PLT<80×109/L);
5. Diagnosed lung diseases (asthma, bronchitis, COPD, Pulmonary bullae,pulmonary embolism, pulmonary edema, lung cancer);
6. 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);
7. 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);
8. 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);
9. Sitting systolic blood pressure ≤90 mmHg during the screening period;
10. Women who are pregnant or breastfeeding;
11. Benzodiazepines, opioids, propofol, lidoca Those who are allergic or contraindicated due to their drug components;
12. Participated in other drug clinical trials as subjects in the past 3 months;
13. The investigator believes that it is not appropriate to participate in this trial;
14. A well-diagnosed heart disease (heart failure, angina pectoris, myocardial infarction, heart rhythmabnormalities etc.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,800 participants in 3 patient groups

Control group

Active Comparator group

Description:

Propofol（1.5mg/kg）

Treatment:

Drug: Propofol

Test group 1（Remimazolam tosylate 0.15mg/kg）

Experimental group

Description:

Remimazolam tosylate 0.15mg/kg

Treatment:

Drug: Remimazolam tosylate

Test group 2（Remimazolam tosylate 0.2mg/kg）

Experimental group

Description:

Remimazolam tosylate 0.2mg/kg

Treatment:

Drug: Remimazolam tosylate