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Effect of Remimazolam With Protocolized Sedation on Critical Ill, Mechanical Ventilated Patients Compared With Midazolam

NCT05160987 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2026-04-17

No results posted yet for this study

Summary

In this parallel, multicenter, single-blind randomized controlled trial, mechanical ventilated patients will be randomly assigned to two groups. One receives remimazolam to achieve sedation goals, while the other receives Midazolam. The primary outcome is the effect of remimazolam on duration of mechanical ventilated of critical patients compared to midazolam.

Conditions

  • Sedation and Analgesia

Interventions

DRUG

Remimazolam

Remimazolam will be diluted with 0.9% saline to ensure that the therapeutic drug and placebo are identical in appearance, and 50 ml syringes will serve as the containers for all intravenous drugs.

DRUG

Midazolam

Midazolam will be diluted with 0.9% saline to ensure that the therapeutic drug and placebo are identical in appearance, and 50 ml syringes will serve as the containers for all intravenous drugs.

Sponsors & Collaborators

  • Integrated traditional Chinese and Western Medicine Hospital of Southern Medical University

    collaborator UNKNOWN

  • First Affiliated Hospital of Shantou University Medical College

    collaborator OTHER

  • Affiliated Hospital of Guangdong Medical University

    collaborator OTHER

  • Yunfu People's Hospital

    collaborator UNKNOWN

  • Zhongshan Hospital Of Traditional Chinese Medicine

    collaborator OTHER

  • Guangdong Province Traditional Medical hospital

    collaborator UNKNOWN

  • The Third Affiliated Hospital of Guangzhou Medical University

    collaborator OTHER

  • Zhujiang Hospital

    lead OTHER

Principal Investigators

  • Zhanguo Liu, M.D.PhD · Department of Critical Care Medicine of Zhujiang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-03-29
Primary Completion
2027-11-30
Completion
2027-12-31

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 NCT05160987 on ClinicalTrials.gov