Status:
UNKNOWN
Efficacy and Safety of Remimazolam Tosylate for Sedation in Gastroscopy
Lead Sponsor:
RenJi Hospital
Collaborating Sponsors:
Shanghai East Hospital
Affiliated Hospital of Jiaxing University
Conditions:
Hypoxia
Gastric Cancer
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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 intraoperat...
Eligibility Criteria
Inclusion
- \- 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
- 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.).
Key Trial Info
Start Date :
March 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
1800 Patients enrolled
Trial Details
Trial ID
NCT04727034
Start Date
March 2 2021
End Date
August 1 2023
Last Update
October 12 2022
Active Locations (5)
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1
Renji Hospital
Shanghai, Shanghai, China, China, 200127
2
Shanghai East Hospital
Shanghai, Shanghai, China, China, 200127
3
Affiliated Hospital of Jiaxing University
Jiaxing, China
4
The Second Affifiliated Hospital of Jiaxing University
Jiaxing, China