A Clinical Study of Remimazolam Tosilate in Patients Undergoing Bronchoscopy

Phase 3

Completed

• Conditions: Sedation
• Interventions: Drug: Remimazolam Tosilate; Drug: Propofol

• Registration Number: NCT04400201
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-14
• Study First Submitted QC: 2020-05-21
• Study First Posted: 2020-05-22
• Study Start: 2020-06-15
• Primary Completion: 2020-10-28
• Study Completion: 2020-10-30
• Last Update Submitted: 2022-08-19
• Last Update Posted: 2022-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Remimazolam Tosilate	Remimazolam Tosilate	-
Propofol	Propofol	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China