A Study of Remimazolam Tosilate for Sedation in the Upper Gastrointestinal Endoscopy

Hengrui Medicine

Status and phase: Completed; Phase 4

Conditions: Sedation in the Upper Gastrointestinal Endoscopy

Treatments: Drug: Remimazolam Tosilate

Study type: Interventional

Funder types: Industry

Identifiers

NCT06169995

HR7056-402

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in Upper Gastrointestinal Endoscopy

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. patients or their guardians are able to provide a written informed consent
2. participants undergo upper gastrointestinal endoscopy
3. ≥18 years old, male or female
4. 18 kg/m2≤bmi≤30kg/m2

Exclusion criteria

1. Subjects to be intubated (including laryngeal mask placement);
2. Complex endoscopic diagnosis and treatment operations are required;
3. Severe cardiovascular disease within 6 months prior to signing the ICF;
4. Heart rate < 50 beats/min during screening period;
5. Subjects with poor blood pressure control during screening;
6. Severe arrhythmias or heart disease; the circulatory system is unstable;
7. Subjects with a history of severe cardiovascular disease, or cerebrovascular disease, or neurological disease, or mental illness
8. Subjects with a history of drug abuse;
9. Abnormal values of the laboratory examination;
10. Allergic to relevant drugs ingredient or component;
11. Pregnant or nursing women;
12. Subjects who has participated in clinical trials of other interventions recently;
13. Other conditions deemed unsuitable to be included.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Remimazolam Tosilate for Injection

Experimental group

Treatment:

Drug: Remimazolam Tosilate