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A Clinical Study of Remimazolam Tosilate in Patients Undergoing Bronchoscopy

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT04400201
Collaborator
(none)
330
Enrollment
1
Location
2
Arms
4.5
Actual Duration (Months)
73.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
330 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Phase III Clinical Study Evaluating the Efficacy and Safety of Remimazolam Tosilate Compared to Propofol in Patients Undergoing Bronchoscopy
Actual Study Start Date :
Jun 15, 2020
Actual Primary Completion Date :
Oct 28, 2020
Actual Study Completion Date :
Oct 30, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  1. 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]

  2. 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]

  3. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking Union Medical College Hospital Beijing China

Sponsors and Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Investigators

  • Principal Investigator: Peking Union Medical College Hospital, Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04400201
Other Study ID Numbers:
  • HR-RMZL-Ⅲ-FB
First Posted:
May 22, 2020
Last Update Posted:
Aug 22, 2022
Last Verified:
May 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Propofol

Study Results

No Results Posted as of Aug 22, 2022