Status:
COMPLETED
A Clinical Study of Remimazolam Tosilate in Patients Undergoing Bronchoscopy
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Sedation
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
A multicenter, randomized, single-blind, active controlled, parallel group study comparing remimazolam tosilate to propofol in patients undergoing bronchoscopy.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2020
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT04400201
Start Date
June 15 2020
End Date
October 30 2020
Last Update
August 22 2022
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China