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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: August 2015

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

  • Drug: Remimazolam Tosilate
    • IV pumping for anesthesia
  • Drug: Propofol
    • IV bolus for anesthesia

Arms, Groups and Cohorts

  • Experimental: Remimazolam Tosilate 1
    • IV pumping of Remimazolam Tosilate at 6mg/kg/h for anesthesia induction
  • Experimental: Remimazolam Tosilate 2
    • intravenous pumping of Remimazolam Tosilate at 12mg/kg/h for anesthesia induction
  • Experimental: Remimazolam Tosilate 3
    • intravenous pumping of Remimazolam Tosilate at 18mg/kg/h for anesthesia induction
  • Active Comparator: Propofol
    • single IV bolus of Propofol at 2.0-2.5mg/kg for anesthesia induction

Clinical Trial Outcome Measures

Primary Measures

  • successful anaesthesia rate as measured by the proportion of subjects who experienced succesful anesthesia during operations
    • Time Frame: an average of 3 hours (immediately after opaerations)

Secondary Measures

  • bispectral index(BIS) during anaesthesia as measured by bispectral index machine
    • Time Frame: every 5 minutes
  • recovery time as measured by time
    • Time Frame: an average of 3 hours (after cessation of anesthetics pumping)
  • induction time as measured by time
    • Time Frame: 1-10 minutes (from the begining of anesthetics)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jiangsu HengRui Medicine Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.