- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04400201
A Clinical Study of Remimazolam Tosilate in Patients Undergoing Bronchoscopy
August 19, 2022 updated by: Jiangsu HengRui Medicine Co., Ltd.
A Phase III Clinical Study Evaluating the Efficacy and Safety of Remimazolam Tosilate Compared to Propofol in Patients Undergoing Bronchoscopy
A multicenter, randomized, single-blind, active controlled, parallel group study comparing remimazolam tosilate to propofol in patients undergoing bronchoscopy.
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
-
-
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Beijing, China
- Peking Union Medical College Hospital
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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 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Remimazolam Tosilate
|
Intravenous injection at a dose of 0.3mg/kg for sedation induction and continuous intravenous infusion at an initiative dose of 1 mg/kg/h for sedation maintenance.
|
ACTIVE_COMPARATOR: Propofol
|
Intravenous injection at a dose of 1.5~2.5mg/kg
for sedation induction and continuous intravenous infusion at the dose of 0~12 mg/kg/h for sedation maintenance
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
From the onset of administration of the study drug to removal of bronchoscope on Day 1 of treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time from start of investigational medicinal product administration to loss of consciousness
Time Frame: From the onset of administration of the study drug to unconsciousness on Day 1 of treatment
|
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
Time Frame: From the last dose of study drug until the patient has recovered to fully alert on Day 1 of treatment
|
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
Time Frame: 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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Peking Union Medical College Hospital, Peking Union Medical College Hospital
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)
June 15, 2020
Primary Completion (ACTUAL)
October 28, 2020
Study Completion (ACTUAL)
October 30, 2020
Study Registration Dates
First Submitted
May 14, 2020
First Submitted That Met QC Criteria
May 21, 2020
First Posted (ACTUAL)
May 22, 2020
Study Record Updates
Last Update Posted (ACTUAL)
August 22, 2022
Last Update Submitted That Met QC Criteria
August 19, 2022
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HR-RMZL-Ⅲ-FB
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.
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