A Clinical Study of Remimazolam Tosilate in Patients Undergoing Bronchoscopy

Hengrui Medicine

Status and phase: Completed; Phase 3

Conditions: Sedation

Treatments: Drug: Propofol; Drug: Remimazolam Tosilate

Study type: Interventional

Funder types: Industry

Identifiers

NCT04400201

HR-RMZL-Ⅲ-FB

Details and patient eligibility

About

A multicenter, randomized, single-blind, active controlled, parallel group study comparing remimazolam tosilate to propofol in patients undergoing bronchoscopy.

Enrollment: 330 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18~80 years, female or male
2. Patients scheduled for an bronchoscopy procedure
3. 18 kg/m2<BMI<30kg/m2
4. Patients understand clearly and participate in the study voluntarily, and sign the informed consent

Exclusion criteria

1. Patients scheduled for emergency surgery
2. Patients with a history of drug abuse and / or alcohol abuse 2 years prior to the screening period
3. One or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.);
4. Pregnant women or those in lactation period
5. Allergic to drugs used in the study
6. Patients have participated in other clinical trial within the 3 months prior to randomization
7. Any patient judged by the Principal Investigator (PI) or Sub-Investigator to be inappropriate for the subject for any other reason

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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330 participants in 2 patient groups

Remimazolam Tosilate

Experimental group

Treatment:

Drug: Remimazolam Tosilate

Propofol

Active Comparator group

Treatment:

Drug: Propofol