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Completed

NCT Number: NCT02406872

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

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.

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Key information

Conditions

General Anesthesia

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remimazolam Tosilate

Drug

IV pumping for anesthesia

Propofol

Drug

IV bolus for anesthesia

Primary outcomes

  1. 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 outcomes

  1. bispectral index(BIS) during anaesthesia as measured by bispectral index machine

    Time frame: every 5 minutes

  2. recovery time as measured by time

    Time frame: an average of 3 hours (after cessation of anesthetics pumping)

  3. induction time as measured by time

    Time frame: 1-10 minutes (from the begining of anesthetics)

Other outcomes

  1. rate of improper-depths sedation as measured by the proportion of subjects who experienced too-deep or too-shallow anesthesia during operations

    Time frame: an average of 3 hours (after anesthesia)

  2. rate of hypotention as measured by the proportion of subjects who experienced hypotention during operations

    Time frame: an average of 3 hours (after anesthesia)

  3. rate of hyoxemia as measured by the proportion of subjects who experienced hyoxemia during operations

    Time frame: an average of 3 hours (after anesthesia)

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 2, 2015
Registry last updated
Dec 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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