At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 164 enrolled
Drug / intervention
Remimazolam besylate +2 moredrug
Likely dose
Remimazolam besylate 2.0mg/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.
A Multicenter, Randomized, Single-blinded, Parallel, Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Injection for Sedation in ICU Patients
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology·interventional·Posted Mar 24, 2023·Updated Jan 31, 2024
In Brief
A Phase 3 clinical trial evaluating Remimazolam besylate, Propofol, and 1 other intervention for Sedative and Mechanical Ventilation. Completed, enrolled 164 participants across 1 site.
Detailed Summary
A randomized non-inferior trial comparing remimazolam besylate with propofol for short-term sedation during invasive mechanical ventilation in intensive care units
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSedative, Mechanical Ventilation
CountriesChina
CollaboratorsYichang Humanwell Pharmaceutical Co., Ltd., China
Timeline
Phase 3CompletedFinished
202420252026
Enrollment StartFeb 2023
First PostedMar 2023
Primary CompletionNov 2023
TodayJul 2026
First PostedMar 24, 2023
Enrollment StartFeb 28, 2023
Primary CompletionNov 25, 2023
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 3.3 years ago
Interventions
Remimazolam besylatedrug
0\~2.0mg/kg/h
Propofoldrug
0.3\~4.0mg/kg/h
Remifentanildrug
1.5\~12μg/kg/h