NCT02406872

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• General Anesthesia

Interventions

Type	Name	Description
DRUG	Remimazolam Tosilate	IV pumping for anesthesia
DRUG	Propofol	IV bolus for anesthesia

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2015-04-02
• Last updated: 2015-12-31

Locations

1 site across 1 country: China