Efficacy and Safety of Remimazolam Tosylate for Sedation in Gastroscopy

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RenJi Hospital
• Collaborators: Jiangxi Provincial People's Hopital; Shanghai East Hospital; The Second Affiliated Hospital of Jiaxing University
• Treatments: Propofol

Criteria

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/m2estimated 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.).