The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550001, China
NCT Number: NCT05913336
The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for prolonged sedation(≥72h) during mechanical ventilation in the ICU.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 1 / Phase 2
Guiyang, Guizhou, 550001, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Loading dose: 0.08mg/kg , Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.1-0.2mg/kg/h
Time frame: within 72 hours after administration of research drug
Time frame: within 72 hours after administration of research drug
Time frame: within 72 hours after administration of research drug
Time frame: within 72 hours after administration of research drug
Time frame: after stopping the research drug
Time frame: follow-up period (approx. 5-10 minutes)
Time frame: at the time of extubation
Jiangsu HengRui Medicine Co., Ltd.
Industry
Evaluating the Efficacy and Safety of Remimazolam Tosilate for Injection for Prolonged Mechanical Ventilation Sedation in the Intensive Care Unit (ICU) - A Non-randomized, Multicenter, Single-arm, Open-label, Proof-of-concept, Phase I/II Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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