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

General Anesthesia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02406872
• Other study ID #: HR7056-002
• Status: Completed
• Phase: Phase 2
• First received: February 15, 2015
• Last updated: December 29, 2015
• Start date: December 2014
• Est. completion date: August 2015

Study information

• Verified date: December 2015
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• General Anesthesia

Intervention

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

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Peking	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	Yes
Other	rate of hypotention as measured by the proportion of subjects who experienced hypotention during operations		an average of 3 hours (after anesthesia)	Yes
Other	rate of hyoxemia as measured by the proportion of subjects who experienced hyoxemia during operations		an average of 3 hours (after anesthesia)	Yes
Primary	successful anaesthesia rate as measured by the proportion of subjects who experienced succesful anesthesia during operations		an average of 3 hours (immediately after opaerations)	No
Secondary	bispectral index(BIS) during anaesthesia as measured by bispectral index machine		every 5 minutes	No
Secondary	recovery time as measured by time		an average of 3 hours (after cessation of anesthetics pumping)	No
Secondary	induction time as measured by time		1-10 minutes (from the begining of anesthetics)	No