A Clinical Study of Remimazolam Tosilate in Patients Undergoing Bronchoscopy

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: Sedation
• Intervention / Treatment: Drug: Remimazolam Tosilate; Drug: Propofol

• Study Type: Interventional
• Enrollment (Actual): 330
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking Union Medical College Hospital

Participation Criteria

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Remimazolam Tosilate	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.
ACTIVE_COMPARATOR: Propofol	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

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	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	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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Investigators: Principal Investigator: Peking Union Medical College Hospital, Peking Union Medical College Hospital

Study record dates

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: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• 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