NCT04400201CompletedPhase 3
A Phase III Clinical Study Evaluating the Efficacy and Safety of Remimazolam Tosilate Compared to Propofol in Patients Undergoing Bronchoscopy
Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country330 target enrollmentStarted: June 15, 2020Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 330
- Locations
- 1
- Primary Endpoint
- Percentage (%) of participants who experienced successful sedation in undergoing bronchoscopy in each group
Study Overview
Brief Summary
A multicenter, randomized, single-blind, active controlled, parallel group study comparing remimazolam tosilate to propofol in patients undergoing bronchoscopy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18~80 years, female or male
- •Patients scheduled for an bronchoscopy procedure
- •18 kg/m2<BMI<30kg/m2
- •Patients understand clearly and participate in the study voluntarily, and sign the informed consent
Exclusion Criteria
- •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 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
Arms & Interventions
Remimazolam Tosilate
Experimental
Intervention: Remimazolam Tosilate (Drug)
Propofol
Active Comparator
Intervention: Propofol (Drug)
Outcomes
Primary Outcomes
Percentage (%) of participants who experienced successful sedation in undergoing bronchoscopy in each group
Time Frame: From the onset of administration of the study drug to removal of bronchoscope on Day 1 of treatment
Secondary Outcomes
- Time from start of investigational medicinal product administration to loss of consciousness(From the onset of administration of the study drug to unconsciousness on Day 1 of treatment)
- Time from stop of investigational medicinal product to MOAA/S Score=5(From the last dose of study drug until the patient has recovered to fully alert on Day 1 of treatment)
- Time from stop of investigational medicinal product to Aldrete Score≥9(From the end of administration of the study drug until the patient reaches the modified Aldrete's system score of ≥9 points on Day 1 of treatment)
Investigators
Study Sites (1)
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