A Study Comparing Remimazolam Tosilate and Propofol for Intravenous General Anaesthesia in Operations

Hengrui Medicine

Status and phase: Completed; Phase 2

Conditions: General Anesthesia

Treatments: Drug: Remimazolam Tosilate; Drug: Propofol

Study type: Interventional

Funder types: Industry

Identifiers

NCT02406872

HR7056-002

Details and patient eligibility

About

The purpose of this study is to find out the optimal dose for Remimazolam Tosilate as an intravenous general anaesthetic drug in operations and to determine its efficacy and safety profile comparing to propofol.

Full description

This is an multi-center，double-blinded，parallel and control study using Remimazolam or propofol for anesthesia in operations.Subjects are randomized to different treatment groups (including 3 for Remimazolam Tosilate and 1 for propofol) and anaesthetics are pumped contimuously into bodies.Analgesics and muscle relaxants are permitted during operations.Efficacy，safety and pharmacokinetic/pharmacodynamic profiles of Remimazolam Tosilate are to be evaluated.

Enrollment: 144 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• subjects aged 18-60 years；
• intending to have non-emergency operations；
• ASA( American Society of Anesthesiologists) I or II；
• 18 kg/m²<BMI(Body Mass Index)<30 kg/m².

Exclusion criteria

• people with contraindications to general anaesthesia;
• one or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.);
• history of recent use of narcotics,analgesics,anaesthetics and benzodiazepine hypnotics;
• history of severe cardiovascular disease;
• uncontrolled blood glucose level;
• cerebral disease or mental disorder;
• allergic to drugs used in the study;
• pregnant women or those in lactation period.

Trial design

144 participants in 4 patient groups

Remimazolam Tosilate 1

Experimental group

Description:

IV pumping of Remimazolam Tosilate at 6mg/kg/h for anesthesia induction

Treatment:

Drug: Remimazolam Tosilate

Remimazolam Tosilate 2

Experimental group

Description:

intravenous pumping of Remimazolam Tosilate at 12mg/kg/h for anesthesia induction

Treatment:

Drug: Remimazolam Tosilate

Remimazolam Tosilate 3

Experimental group

Description:

intravenous pumping of Remimazolam Tosilate at 18mg/kg/h for anesthesia induction

Treatment:

Drug: Remimazolam Tosilate

Propofol

Active Comparator group

Description:

single IV bolus of Propofol at 2.0-2.5mg/kg for anesthesia induction

Treatment:

Drug: Propofol