A Clinical Study of Remimazolam Tosilate in Patients Undergoing Bronchoscopy

Sedation Clinical Trial

Official title:

A Phase III Clinical Study Evaluating the Efficacy and Safety of Remimazolam Tosilate Compared to Propofol in Patients Undergoing Bronchoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04400201
• Other study ID #: HR-RMZL-?-FB
• Status: Completed
• Phase: Phase 3
• Start date: June 15, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: May 2020
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A multicenter, randomized, single-blind, active controlled, parallel group study comparing remimazolam tosilate to propofol in patients undergoing bronchoscopy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: October 30, 2020
• Est. primary completion date: October 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 18~80 years, female or male

2. Patients scheduled for an bronchoscopy procedure

3. 18 kg/m2<BMI<30kg/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 have participated in other clinical trial within the 3 months prior to randomization

7. Any patient judged by the Principal Investigator (PI) or Sub-Investigator to be inappropriate for the subject for any other reason

Related Conditions & MeSH terms

• Sedation

Intervention

Drug:
• 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.
• 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

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage (%) of participants who experienced successful sedation in undergoing bronchoscopy in each group		From the onset of administration of the study drug to removal of bronchoscope on Day 1 of treatment
Secondary	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
Secondary	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
Secondary	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