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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03921775
Recruitment Status : Completed
First Posted : April 19, 2019
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Anesthesia for Elective Surgery Patients Drug: Remimazolam Tosilate Drug: Propofol Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : May 13, 2019
Actual Primary Completion Date : December 30, 2019
Actual Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Percentage(%) of paticipants who experienced successful anesthesia during operation in each group [ Time Frame: Average of 2 hours ]

Secondary Outcome Measures :
  1. Time from start of investigational medicinal product administration to loss of consciousness [ Time Frame: Average of 2 hours ]
  2. Time from stop of investigational medicinal product to MOAA/S Score=5 [ Time Frame: Average of 2 hours ]
  3. Time from stop of investigational medicinal product to Aldrete Score>9 [ Time Frame: Average of 2 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921775


Locations
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China, Beijing
Peking Union Medical College Hospital
Beijing, Beijing, China, 010
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
More Information
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03921775    
Other Study ID Numbers: HR-RMZL-Ⅲ-GA
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
 Anesthetics, Intravenous
Anesthetics, General
Anesthetics