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

NCT ID: NCT02406872

Last Updated: 2015-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-08-31

Brief Summary

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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

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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

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General Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Remimazolam Tosilate 1

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

Group Type EXPERIMENTAL

Remimazolam Tosilate

Intervention Type DRUG

IV pumping for anesthesia

Remimazolam Tosilate 2

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

Group Type EXPERIMENTAL

Remimazolam Tosilate

Intervention Type DRUG

IV pumping for anesthesia

Remimazolam Tosilate 3

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

Group Type EXPERIMENTAL

Remimazolam Tosilate

Intervention Type DRUG

IV pumping for anesthesia

Propofol

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

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

IV bolus for anesthesia

Interventions

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Remimazolam Tosilate

IV pumping for anesthesia

Intervention Type DRUG

Propofol

IV bolus for anesthesia

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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HR7056-002

Identifier Type: -

Identifier Source: org_study_id