Efficacy and Safety of Remimazolam Tosylate for Sedation in Gastroscopy

NCT ID: NCT04727034

Last Updated: 2022-10-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-02
• Study Completion Date: 2023-08-01

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.

Conditions

Hypoxia; Gastric Cancer; Sedation Complication; Propofol Adverse Reaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control group

Propofol（1.5mg/kg）

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

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.

Test group 1（Remimazolam tosylate 0.15mg/kg）

Remimazolam tosylate 0.15mg/kg

Group Type: EXPERIMENTAL

Remimazolam tosylate

Intervention Type: DRUG

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.

Test group 2（Remimazolam tosylate 0.2mg/kg）

Remimazolam tosylate 0.2mg/kg

Group Type: EXPERIMENTAL

Remimazolam tosylate

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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.).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai East Hospital

OTHER

Sponsor Role: collaborator

Affiliated Hospital of Jiaxing University

OTHER

Sponsor Role: collaborator

The Second Affifiliated Hospital of Jiaxing University

UNKNOWN

Sponsor Role: collaborator

The First Affiliated Hospital of Nanchang University

OTHER

Sponsor Role: collaborator

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

diansan su

Vice Chair of the Department of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Renji Hospital

Shanghai, Shanghai, China, China

Site Status: RECRUITING

Shanghai East Hospital

Shanghai, Shanghai, China, China

Site Status: RECRUITING

Affiliated Hospital of Jiaxing University

Jiaxing, , China

Site Status: RECRUITING

The Second Affifiliated Hospital of Jiaxing University

Jiaxing, , China

Site Status: RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Diansan Su, Dr.

Role: CONTACT

diansansu@yahoo.com

+862168383702

Huichen zhu, M.S.

Role: CONTACT

diansansu@yahoo.com

+862168383702

Facility Contacts

Diansan Su, Dr.

Role: primary

diansansu@yahoo.com

+862168383702

Xiangrui D Wang, Dr.

Role: primary

13701901953

Ming Yao, PhD

Role: primary

jxyaoming@163.com

13758394990

Hongmei zhou

Role: primary

13867300139

shibiao chen

Role: primary

chenlaoshi1111@163.com

13870892918

References

Zhu H, Su Z, Huai X, Chen C, Zhang X, Zhou J, Su D. Efficacy and safety of remimazolam tosylate for sedation during upper gastrointestinal endoscopy: study protocol for a multicenter randomized controlled trial. Trials. 2022 Dec 12;23(1):995. doi: 10.1186/s13063-022-06935-0.

Reference Type: DERIVED

PMID: 36510290 (View on PubMed)

Other Identifiers

sudiansan1215

Identifier Type: -

Identifier Source: org_study_id