Efficacy and Safety of Remimazolam Tosylate for Sedation in Gastroscopy

Last updated: October 7, 2022
Sponsor: RenJi Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastric Cancer

Treatment

N/A

Clinical Study ID

NCT04727034
sudiansan1215
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 1)18≤age≤60 years old, no gender limit; 2) Patients receiving routine gastroscopydiagnosis and treatment; 3) ASA score is I or II; 4) 18 kg/m2<BMI<28kg/m2; 5) It isestimated that the operation time of gastroscope will not exceed 30 minutes; 6) Clearlyunderstand, voluntarily participate in the research, and be signed and informed consent.

Exclusion

Exclusion Criteria:

  1. Need to perform complicated endoscopic diagnosis and treatment techniques (such ascholangiopancreatography Surgery, endoscopic ultrasonography, endoscopic mucosalresection, 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 Mallampatiscore is IV)patient;
  4. Anemia or thrombocytopenia,( Hb<90g/L, PLT<80×109/L);
  5. Diagnosed lung diseases (asthma, bronchitis, COPD, Pulmonary bullae,pulmonaryembolism, pulmonary edema, lung cancer);
  6. Liver and kidney disease;( AST and/or ALT≥2.5×ULN,TBIL≥1.5×ULN, blood creatinine isgreater than the upper limit of normal);
  7. There is a history of drug and/or alcohol abuse within 2 years before the beginning ofthe 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 grapesliqueur);
  8. Hypertensive patients whose blood pressure has not been satisfactorily controlled byantihypertensive drugs(Sitting systolic blood pressure ≥160 mmHg during screeningperiod, 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 contraindicateddue 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.).

Study Design

Total Participants: 1800
Study Start date:
March 02, 2021
Estimated Completion Date:
August 01, 2023

Connect with a study center

  • Renji Hospital

    Shanghai, Shanghai, China 200127
    China

    Active - Recruiting

  • Shanghai East Hospital

    Shanghai, Shanghai, China 200127
    China

    Active - Recruiting

  • Affiliated Hospital of Jiaxing University

    Jiaxing,
    China

    Active - Recruiting

  • The Second Affifiliated Hospital of Jiaxing University

    Jiaxing,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang,
    China

    Active - Recruiting

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