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

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.

Study Overview

• Status: Completed
• Conditions: General Anesthesia
• Intervention / Treatment: Drug: Remimazolam Tosilate; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Peking, Beijing, China
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remimazolam Tosilate 1; IV pumping of Remimazolam Tosilate at 6mg/kg/h for anesthesia induction	Drug: Remimazolam Tosilate; IV pumping for anesthesia
Experimental: Remimazolam Tosilate 2; intravenous pumping of Remimazolam Tosilate at 12mg/kg/h for anesthesia induction	Drug: Remimazolam Tosilate; IV pumping for anesthesia
Experimental: Remimazolam Tosilate 3; intravenous pumping of Remimazolam Tosilate at 18mg/kg/h for anesthesia induction	Drug: Remimazolam Tosilate; IV pumping for anesthesia
Active Comparator: Propofol; single IV bolus of Propofol at 2.0-2.5mg/kg for anesthesia induction	Drug: Propofol; IV bolus for anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: February 15, 2015
• First Submitted That Met QC Criteria: March 30, 2015
• First Posted (Estimate): April 2, 2015

Study Record Updates

• Last Update Posted (Estimate): December 31, 2015
• Last Update Submitted That Met QC Criteria: December 29, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: HR7056-002