Remimazolam for Sedation in ICU Patients Undergoing Mechanical Ventilation
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Sedation
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 90 years
- Gender
- Both males and females
Description
Title: Efficacy and Safety of Remimazolam for Sedation in ICU Patients Undergoing Mechanical Ventilation Research center: Single Center The Design of the study: Randomized, Controlled, Non-inferiority Trial The population of the study: The main inclusion criteria are 18 years old or above, invasive ...
Title: Efficacy and Safety of Remimazolam for Sedation in ICU Patients Undergoing Mechanical Ventilation Research center: Single Center The Design of the study: Randomized, Controlled, Non-inferiority Trial The population of the study: The main inclusion criteria are 18 years old or above, invasive mechanical ventilation is required, and the clinical need is mild to moderate Sedated (RASS score 0 to -3) patients Sample size: Enroll 488 patients (244patients in each group) Interventions: Participants in the test group received remimazolam for sedation, while participants in the control group received dexmedetomidine, The analgesia drug in two group is fentanyl. The aim of the research: To investigate the efficacy and safety of remimazolam for sedation in ICU patients undergoing mechanical ventilation Outcome# 1) Primary outcome# the ratio of the time to reach the target sedation (RASS score, 0 to -3)in the total duration of drug infusion, and the duration of mechanical ventilation. 2)Secondary outcome#; Length of stay in ICU and Length of stay in hospital; Incidence of complications (including re-hospitalization); Total expenses during hospitalization The estimated duration of the study#2-3years
Tracking Information
- NCT #
- NCT04815265
- Collaborators
- Not Provided
- Investigators
- Study Chair: Jianbo Yu Tianjin Nankai Hospital