A Study of Remimazolam Tosilate for Sedation in Non-intubated Diagnostic and Therapeutic Procedures

Hengrui Medicine

Status and phase: Not yet enrolling; Phase 4

Conditions: Sedation in Non-intubated Diagnostic and Therapeutic Procedures

Treatments: Drug: Remimazolam Tosilate for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06216444

HR7056-401

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 non-intubated diagnostic and therapeutic procedures

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18 years old, male or female
2. Intending to undergo routine gastroscopy or colonoscopy
3. ASA (American Society of Anesthesiologists) I to III
4. 18 kg/m2≤BMI (Body Mass Index)≤30kg/m2
5. Signed informed consent

Exclusion criteria

1. Subjects need to be tracheal intubation
2. Subjects need to be complicated endoscopic diagnostic and therapeutic procedures
3. Subjects who have had severe cardiovascular diseases or severe arrhythmias within 6 months prior to signing the ICF
4. Heart rate <50 beats/min during the screening period
5. Poor blood pressure control during the screening period
6. Subjects with severe respiratory diseases
7. Subjects with respiratory management difficulties (Modified Mallampati grade IV)
8. Subjects with a history of mental illness (schizophrenia, mania, bipolar disorder, psychosis, etc.), long-term use of psychotropic drugs, and cognitive impairment
9. A history of drug abuse or addiction within 2 years prior to signing the ICF
10. Pregnant women or those in lactation period
11. Allergic to relevant drugs ingredient or component in the study
12. Currently participating in or planning to participate in other drug or device clinical trials during this study
13. Other conditions deemed unsuitable to be included

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 2 patient groups

Remimazolam Tosilate for Injection（5mg）

Experimental group

Treatment:

Drug: Remimazolam Tosilate for Injection

Drug: Remimazolam Tosilate for Injection

Remimazolam Tosilate for Injection（10mg）

Experimental group

Treatment:

Drug: Remimazolam Tosilate for Injection

Drug: Remimazolam Tosilate for Injection