General Anesthesia
Conditions
Brief summary
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.
Detailed 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.
Interventions
IV pumping for anesthesia
DRUGPropofol
IV bolus for anesthesia
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| successful anaesthesia rate as measured by the proportion of subjects who experienced succesful anesthesia during operations | an average of 3 hours (immediately after opaerations) |
Secondary
| Measure | Time frame |
|---|---|
| bispectral index(BIS) during anaesthesia as measured by bispectral index machine | every 5 minutes |
| recovery time as measured by time | an average of 3 hours (after cessation of anesthetics pumping) |
| induction time as measured by time | 1-10 minutes (from the begining of anesthetics) |
Other
| Measure | Time frame |
|---|---|
| rate of hypotention as measured by the proportion of subjects who experienced hypotention during operations | an average of 3 hours (after anesthesia) |
| rate of hyoxemia as measured by the proportion of subjects who experienced hyoxemia during operations | an average of 3 hours (after anesthesia) |
| rate of improper-depths sedation as measured by the proportion of subjects who experienced too-deep or too-shallow anesthesia during operations | an average of 3 hours (after anesthesia) |
Countries
China
Outcome results
None listed