A Clinical Study of Remimazolam Tosilate in Patients Undergoing Bronchoscopy

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 30, 2020

Interventions

  • 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.
  • Drug: 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

Arms, Groups and Cohorts

  • Experimental: Remimazolam Tosilate
  • Active Comparator: Propofol

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jiangsu HengRui Medicine Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Peking Union Medical College Hospital, Principal Investigator, Peking Union Medical College Hospital
  • Overall Contact(s)
    • Jiangsu HengRui Medicine Co., Ltd.

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