CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
Remimazolam Tosilate +1 moredrug
Likely dose
Remimazolam Tosilate 0.08mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05152303
NCT05152303Phase 2Completed

Efficacy and Safety of Remimazolam Tosilate for Injection for Sedation in the Intensive Care Unit (ICU) - a Multicenter, Randomized, Single Blind, Dose Finding Phase II Clinical Trial

Fujian Shengdi Pharmaceutical Co., Ltd.·interventional·Posted Dec 9, 2021·Updated May 23, 2023

In Brief

A Phase 2 clinical trial evaluating Remimazolam Tosilate for Sedation in the ICU. Completed, enrolled 60 participants across 1 site.

Detailed Summary

The purpose of this study is to explore the optimal dose regimen of Remimazolam Tosilate for Injection for sedation in the ICU, as well as preliminarily evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in the ICU.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedDec 9, 2021
Enrollment StartOct 12, 2022
Primary CompletionApr 2, 2023
Study CompletionApr 19, 2023
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 4.6 years ago

Interventions

Remimazolam Tosilatedrug

Loading dose: 0.08mg/kg IV of Remimazolam Tosilate, Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.1mg/kg/h

Remimazolam Tosilatedrug

Loading dose: 0.08mg/kg, Drug: Propofol Injection Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.2mg/kg/h IV of Propofol Injection