A Clinical Study of Remimazolam Tosilate Compared to Propofol for General Anesthesia During Elective Surgery

May 14, 2020 updated by: Jiangsu HengRui Medicine Co., Ltd.

A Multicenter, Randomized, Single-blind, Parallel and Control Phase III Trial Evaluating the Efficacy and Safety of Remimazolam Tosilate Compared to Propofol for General Anesthesia During Elective Surgery.

The study is being conducted to evaluate the efficacy and safety of remimazolam tosilate compared to propofol for general anesthesia during elective surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

330

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 010
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclution Criteria:

  1. 18~60 years, female or male
  2. Patients scheduled for an elective surgical procedure(mechanical ventilation via endotracheal tube)
  3. BMI: 18~30 kg/m2
  4. Patients understand clearly and participate in the study voluntarily, and sign the informed consent

Exclusion criteria:

  1. Patients scheduled for emergency surgery
  2. Patients with a history of drug abuse and / or alcohol abuse 2 years prior to the screening period
  3. One or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.)
  4. Pregnant women or those in lactation period
  5. Allergic to drugs used in the study
  6. Patients with respiratory management difficulties (Modified Mallampati grade IV)
  7. Patients have participated in other clinical trial within the 3 months prior to randomization
  8. Any patient judged by the Principal Investigator (PI) or Sub-Investigator to be inappropriate for the subject for any other reason

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group A
IV pumping of remimazolam tosilate at 6mg/kg/h for anesthesia induction and 1mg/kg/h for anesthesia maintenance
Drug: Remimazolam Tosilate
For induction and maintenance of general anesthesia
Active Comparator: Treatment B
IV pumping of propofol at 120~150mg/kg/h for anesthesia induction and 3~12mg/kg/h for anesthesia maintenance
Drug: Propofol
For induction and maintenance of general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage(%) of paticipants who experienced successful anesthesia during operation in each group
Time Frame: Average of 2 hours
Average of 2 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Time from start of investigational medicinal product administration to loss of consciousness
Time Frame: Average of 2 hours
Average of 2 hours
Time from stop of investigational medicinal product to MOAA/S Score=5
Time Frame: Average of 2 hours
Average of 2 hours
Time from stop of investigational medicinal product to Aldrete Score>9
Time Frame: Average of 2 hours
Average of 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2019

Primary Completion (Actual)

December 30, 2019

Study Completion (Actual)

December 30, 2019

Study Registration Dates

First Submitted

April 15, 2019

First Submitted That Met QC Criteria

April 17, 2019

First Posted (Actual)

April 19, 2019

Study Record Updates

Last Update Posted (Actual)

May 15, 2020

Last Update Submitted That Met QC Criteria

May 14, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HR-RMZL-Ⅲ-GA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anesthesia for Elective Surgery Patients

Clinical Trials on Propofol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe