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A Clinical Study of Remimazolam Tosilate in Patients Undergoing Bronchoscopy

NCT04400201 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2022-08-22

No results posted yet for this study

Summary

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

Conditions

  • Sedation

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

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Peking Union Medical College Hospital · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-15
Primary Completion
2020-10-28
Completion
2020-10-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04400201 on ClinicalTrials.gov