Efficacy and Safety of Remimazolam Tosylate for Sedation in Gastroscopy

Sponsor

RenJi Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04727034

Collaborator

Shanghai East Hospital (Other), Jiangxi Provincial People's Hopital (Other), The Second Affiliated Hospital of Jiaxing University (Other)

1,800

Enrollment

Locations

Arms

Anticipated Duration (Months)

450

Patients Per Site

26.5

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Mar 2, 2021

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

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.

Arm

Intervention/Treatment

Active Comparator: Control group

Propofol（1.5mg/kg）

Drug: Propofol

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

Outcome Measures

Primary Outcome Measures

The success rate of remazolam tosylate for sedation in gastroscopy diagnosis and treatment [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

Sedation induction time [Patients will be followed for the duration of hospital stay, an expected average of 2 hours]
induction time
Sedation recovery time [Patients will be followed for the duration of hospital stay, an expected average of 2 hours]
recovery time
Incidence of drug injection pain [Patients will be followed for the duration of hospital stay, an expected average of 2 hours]
drug injection pain
Doctor satisfaction and patient satisfaction [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.
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; [Patients will be followed for the duration of hospital stay, an expected average of 2 hours]
Sedation/Anaesthesia Discharge Rating Scale
The incidence of hypoxia during sedation [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)
Other adverse events assessed by the World SIVA adverse sedation event reporting tool [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Renji Hospital	Shanghai	Shanghai, China	China	200127
2	Shanghai Oriental Hospital	Shanghai	Shanghai, China	China	200127
3	Jiaxing Second Hospital	Jiaxing		China
4	Jiangxi Provincial People's Hospital	Nanchang		China