Recruitment

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