A Clinical Study of Remimazolam Tosilate Compared to Propofol for General Anesthesia During Elective Surgery
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.
1 other identifier
interventional
330
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2019
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2019
CompletedFirst Posted
Study publicly available on registry
April 19, 2019
CompletedStudy Start
First participant enrolled
May 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedMay 15, 2020
May 1, 2020
8 months
April 15, 2019
May 14, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage(%) of paticipants who experienced successful anesthesia during operation in each group
Average of 2 hours
Secondary Outcomes (3)
Time from start of investigational medicinal product administration to loss of consciousness
Average of 2 hours
Time from stop of investigational medicinal product to MOAA/S Score=5
Average of 2 hours
Time from stop of investigational medicinal product to Aldrete Score>9
Average of 2 hours
Study Arms (2)
Treatment group A
EXPERIMENTALIV pumping of remimazolam tosilate at 6mg/kg/h for anesthesia induction and 1mg/kg/h for anesthesia maintenance
Treatment B
ACTIVE COMPARATORIV pumping of propofol at 120\~150mg/kg/h for anesthesia induction and 3\~12mg/kg/h for anesthesia maintenance
Interventions
Eligibility Criteria
You may not qualify if:
- Patients scheduled for emergency surgery
- Patients with a history of drug abuse and / or alcohol abuse 2 years prior to the screening period
- One or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.)
- Pregnant women or those in lactation period
- Allergic to drugs used in the study
- Patients with respiratory management difficulties (Modified Mallampati grade IV)
- Patients have participated in other clinical trial within the 3 months prior to randomization
- Any patient judged by the Principal Investigator (PI) or Sub-Investigator to be inappropriate for the subject for any other reason
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 010, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2019
First Posted
April 19, 2019
Study Start
May 13, 2019
Primary Completion
December 30, 2019
Study Completion
December 30, 2019
Last Updated
May 15, 2020
Record last verified: 2020-05