Efficacy and Safety of Remimazolam Tosylate for Sedation in Gastroscopy

Study Overview
=================
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.

Official Title
-----------------
A Multicenter, Randomized, Single-blind, Parallel Controlled Clinical Study on the Efficacy and Safety of Remimazolam Tosylate for Sedation in Gastroscopy

Conditions
-----------------
Hypoxia, Gastric Cancer, Sedation Complication, Propofol Adverse Reaction

Intervention / Treatment
-----------------
* Drug: Remimazolam tosylate
* Drug: Propofol


Participation Criteria
=================
Eligibility 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: 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.).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Propofol（1.5mg/kg） | Drug: Propofol<br>* 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.<br>|
| Experimental: Test group 1（Remimazolam tosylate 0.15mg/kg）<br>Remimazolam tosylate 0.15mg/kg | Drug: Remimazolam tosylate<br>* 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.<br>|
| Experimental: Test group 2（Remimazolam tosylate 0.2mg/kg）<br>Remimazolam tosylate 0.2mg/kg | Drug: Remimazolam tosylate<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The success rate of remazolam tosylate for sedation in gastroscopy diagnosis and treatment | 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 | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedation induction time | induction time | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | 
| Sedation recovery time | recovery time | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | 
| Incidence of drug injection pain | drug injection pain | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | 
| Doctor satisfaction and patient satisfaction | 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. | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | 
| 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; | Sedation/Anaesthesia Discharge Rating Scale | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | 
| The incidence of hypoxia during sedation | (75% ≤ SpO2 < 90% for <60 s)；(SpO2 < 75% for any duration or 75% < SpO2 < 90% for >/=60 s) | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | 
| Other adverse events assessed by the World SIVA adverse sedation event reporting tool | 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. | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Propofol, Hypoxia, Efficacy and Safety, Gastroscope, Remimazolam