A Study Comparing Remimazolam Tosilate and Propofol for Intravenous General Anaesthesia in Operations
- Registration Number
- NCT02406872
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 144
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Remimazolam Tosilate 1 Remimazolam Tosilate IV pumping of Remimazolam Tosilate at 6mg/kg/h for anesthesia induction Remimazolam Tosilate 2 Remimazolam Tosilate intravenous pumping of Remimazolam Tosilate at 12mg/kg/h for anesthesia induction Remimazolam Tosilate 3 Remimazolam Tosilate intravenous pumping of Remimazolam Tosilate at 18mg/kg/h for anesthesia induction Propofol Propofol single IV bolus of Propofol at 2.0-2.5mg/kg for anesthesia induction
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (1)
Peking Union Medical College Hospital
🇨🇳Peking, Beijing, China