Clinical trial NCT04727034: Efficacy and Safety of Remimazolam Tosylate for Sedation in Gastroscopy
Official title: A Multicenter, Randomized, Single-blind, Parallel Controlled Clinical Study on the Efficacy and Safety of Remimazolam Tosylate for Sedation in Gastroscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypoxia
Gastric Cancer
Sedation Complication
Propofol Adverse Reaction
Keywords: Hypoxia
Efficacy and Safety
Gastroscope
Remimazolam
Propofol
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai East Hospital
name: Affiliated Hospital of Jiaxing University
name: The Second Affifiliated Hospital of Jiaxing University
name: The First Affiliated Hospital of Nanchang University
First posted: 2021-01-27
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

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.).

Primary outcomes:
measure: The success rate of remazolam tosylate for sedation in gastroscopy diagnosis and treatment
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary outcomes:
measure: Sedation induction time
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
measure: Sedation recovery time
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
measure: Incidence of drug injection pain
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
measure: Doctor satisfaction and patient satisfaction
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
measure: 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;
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
measure: The incidence of hypoxia during sedation
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
measure: Other adverse events assessed by the World SIVA adverse sedation event reporting tool
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai, China
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai, China
city: Jiaxing
country: China
facility: Affiliated Hospital of Jiaxing University
city: Jiaxing
country: China
facility: The Second Affifiliated Hospital of Jiaxing University
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
Study officials:
References: