A Clinical Study of Remimazolam Tosilate in Patients Undergoing Bronchoscopy

NCT04400201 | Completed Phase 3

• 1 other identifier: HR-RMZL-Ⅲ-FB
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sedation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Remimazolam Tosilate

EXPERIMENTAL

Drug: Remimazolam Tosilate

Propofol

ACTIVE COMPARATOR

Drug: Propofol

Interventions

Remimazolam Tosilate DRUG

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.

Remimazolam Tosilate

Propofol DRUG

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

Propofol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \~80 years, female or male
• Patients scheduled for an bronchoscopy procedure
• kg/m2\<BMI\<30kg/m2
• Patients understand clearly and participate in the study voluntarily, and sign the informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Peking Union Medical College Hospital

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 22, 2020
• Study Start: June 15, 2020
• Primary Completion: October 28, 2020
• Study Completion: October 30, 2020
• Last Updated: August 22, 2022

Record last verified: 2020-05

Locations

CN (1)