A Clinical Study of Remimazolam Tosilate Compared to Propofol for General Anesthesia During Elective Surgery

Hengrui Medicine

Status and phase: Completed; Phase 3

Conditions: Anesthesia for Elective Surgery Patients

Treatments: Drug: Remimazolam Tosilate; Drug: Propofol

Study type: Interventional

Funder types: Industry

Identifiers

NCT03921775

HR-RMZL-Ⅲ-GA

Details and patient eligibility

About

The study is being conducted to evaluate the efficacy and safety of remimazolam tosilate compared to propofol for general anesthesia during elective surgery.

Enrollment: 330 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclution Criteria:

1. 18~60 years, female or male
2. Patients scheduled for an elective surgical procedure(mechanical ventilation via endotracheal tube)
3. BMI: 18~30 kg/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 with respiratory management difficulties (Modified Mallampati grade IV)
7. Patients have participated in other clinical trial within the 3 months prior to randomization
8. 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: Parallel Assignment

Masking: Single Blind

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330 participants in 2 patient groups

Treatment group A

Experimental group

Description:

IV pumping of remimazolam tosilate at 6mg/kg/h for anesthesia induction and 1mg/kg/h for anesthesia maintenance

Treatment:

Drug: Remimazolam Tosilate

Treatment B

Active Comparator group

Description:

IV pumping of propofol at 120\~150mg/kg/h for anesthesia induction and 3\~12mg/kg/h for anesthesia maintenance

Treatment:

Drug: Propofol