Clinical trial NCT02406872: A Study Comparing Remimazolam Tosilate and Propofol for Intravenous General Anaesthesia in Operations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: General Anesthesia
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-04-02
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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.

Primary outcomes:
measure: successful anaesthesia rate as measured by the proportion of subjects who experienced succesful anesthesia during operations
timeFrame: an average of 3 hours (immediately after opaerations)
Secondary outcomes:
measure: bispectral index(BIS) during anaesthesia as measured by bispectral index machine
timeFrame: every 5 minutes
measure: recovery time as measured by time
timeFrame: an average of 3 hours (after cessation of anesthetics pumping)
measure: induction time as measured by time
timeFrame: 1-10 minutes (from the begining of anesthetics)
Other outcomes:
measure: rate of improper-depths sedation as measured by the proportion of subjects who experienced too-deep or too-shallow anesthesia during operations
timeFrame: an average of 3 hours (after anesthesia)
measure: rate of hypotention as measured by the proportion of subjects who experienced hypotention during operations
timeFrame: an average of 3 hours (after anesthesia)
measure: rate of hyoxemia as measured by the proportion of subjects who experienced hyoxemia during operations
timeFrame: an average of 3 hours (after anesthesia)
Locations:
city: Peking
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References: