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

NCT02406872 | Completed Phase 2 DMC

• 1 other identifier: HR7056-002
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

General Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 Outcomes (3)

• 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)

Study Arms (4)

Remimazolam Tosilate 1

EXPERIMENTAL

IV pumping of Remimazolam Tosilate at 6mg/kg/h for anesthesia induction

Drug: Remimazolam Tosilate

Remimazolam Tosilate 2

EXPERIMENTAL

intravenous pumping of Remimazolam Tosilate at 12mg/kg/h for anesthesia induction

Drug: Remimazolam Tosilate

Remimazolam Tosilate 3

EXPERIMENTAL

intravenous pumping of Remimazolam Tosilate at 18mg/kg/h for anesthesia induction

Drug: Remimazolam Tosilate

Propofol

ACTIVE COMPARATOR

single IV bolus of Propofol at 2.0-2.5mg/kg for anesthesia induction

Drug: Propofol

Interventions

Remimazolam Tosilate DRUG

IV pumping for anesthesia

Remimazolam Tosilate 1; Remimazolam Tosilate 2; Remimazolam Tosilate 3

Propofol DRUG

IV bolus for anesthesia

Propofol

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• subjects aged 18-60 years；
• intending to have non-emergency operations；
• ASA( American Society of Anesthesiologists) I or II；
• kg/m²\<BMI(Body Mass Index)\<30 kg/m².

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2015
• First Posted: April 2, 2015
• Study Start: December 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 31, 2015

Record last verified: 2015-12

Locations

CN (1)