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Efficacy and Safety of Remimazolam Tosylate for Sedation in Gastroscopy

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ClinicalTrials.gov Identifier: NCT04727034
Recruitment Status : Recruiting
First Posted : January 27, 2021
Last Update Posted : March 5, 2021
Sponsor:
Collaborators:
Shanghai East Hospital
Jiangxi Provincial People's Hopital
The Second Affiliated Hospital of Jiaxing University
Information provided by (Responsible Party):
diansan su, RenJi Hospital

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 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.

Condition or disease Intervention/treatment Phase
Hypoxia Gastric Cancer Sedation Complication Propofol Adverse Reaction Drug: Remimazolam tosylate Drug: Propofol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Single-blind, Parallel Controlled Clinical Study on the Efficacy and Safety of Remimazolam Tosylate for Sedation in Gastroscopy
Actual Study Start Date : March 2, 2021
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Arm Intervention/treatment
Active Comparator: Control group
Propofol(1.5mg/kg)
Drug: Propofol
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.

Experimental: Test group 1(Remimazolam tosylate 0.15mg/kg)
Remimazolam tosylate 0.15mg/kg
Drug: Remimazolam tosylate
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.

Experimental: Test group 2(Remimazolam tosylate 0.2mg/kg)
Remimazolam tosylate 0.2mg/kg
Drug: Remimazolam tosylate
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.




Primary Outcome Measures :
  1. The success rate of remazolam tosylate for sedation in gastroscopy diagnosis and treatment [ Time Frame: 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


Secondary Outcome Measures :
  1. Sedation induction time [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours ]
    induction time

  2. Sedation recovery time [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours ]
    recovery time

  3. Incidence of drug injection pain [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours ]
    drug injection pain

  4. Doctor satisfaction and patient satisfaction [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours ]
    There is a scale from 1 to 10. Endoscopists and patients will score their satisfaction with the scale ,with 1-3 (dissatisfied),4-6 (satisfied) and 7-10 (very satisfied) after gastroscopy.

  5. 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; [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours ]
    Sedation/Anaesthesia Discharge Rating Scale

  6. The incidence of hypoxia during sedation [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours ]
    (75% ≤ SpO2 < 90% for <60 s);(SpO2 < 75% for any duration or 75% < SpO2 < 90% for >/=60 s)

  7. Other adverse events assessed by the World SIVA adverse sedation event reporting tool [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours ]
    other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force and HFNC supportive oxygen therapy-related adverse events.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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/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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04727034


Contacts
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Contact: Diansan Su, Dr. +862168383702 diansansu@yahoo.com
Contact: Huichen zhu, M.S. +862168383702 diansansu@yahoo.com

Locations
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China, Shanghai, China
Renji Hospital Recruiting
Shanghai, Shanghai, China, China, 200127
Contact: Diansan Su, Dr.    +862168383702    diansansu@yahoo.com   
Shanghai Oriental Hospital Recruiting
Shanghai, Shanghai, China, China, 200127
Contact: Xiangrui D Wang, Dr.    13701901953      
China
Jiaxing Second Hospital Recruiting
Jiaxing, China
Contact: Hongmei zhou    13867300139      
Jiangxi Provincial People's Hospital Recruiting
Nanchang, China
Contact: Mingsheng zhang    13807915056      
Sponsors and Collaborators
RenJi Hospital
Shanghai East Hospital
Jiangxi Provincial People's Hopital
The Second Affiliated Hospital of Jiaxing University
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Responsible Party: diansan su, Vice Chair of the Department of Anesthesiology, RenJi Hospital
ClinicalTrials.gov Identifier: NCT04727034    
Other Study ID Numbers: sudiansan1215
First Posted: January 27, 2021    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by diansan su, RenJi Hospital:
Hypoxia
Efficacy and Safety
Gastroscope
Remimazolam
Propofol
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics