drugset / Trial / NCT02080169
Safety and Efficacy of Combined Sedation With Midazolam and Dexmedetomidine in ICU Patients
Phase 4
Unknown
600 enrolled
Qilu Hospital of Shandong University
Chinese Medical Association · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
It is well known that ICU patients need sedation. Now no ideal sedation drug existed and every sedation drug has its advantage and disadvantage,so combined sedation may use the advantage and avoid the disadvantage of the sedation drug according to the patients'condition. Until now, there is rare study about the combined sedation or sequenced sedation of different sedation drug.The purpose of the study is to explore the value of combined sedation with midazolam and dexmedetomidine compared to single drug sedation in ICU, so as to seek an ideal sedation protocol that could reduce the cost of treatment,obtain the appropriate sedation not under sedation or over sedation,reduce the incidence of delirium, reduce the adverse event of sedation.
Timeline
- Start
- 2014-02
- Primary completion
- 2014-12
- Completion
- 2014-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexmedetomidine | Other / unclassified | 0.2 ug/kg | Intravenous |
| Subject | Dexmedetomidine | Other / unclassified | 0.7 ug/kg | Intravenous |
| Subject | Midazolam | Small molecule | 0.01 mg/kg | Intravenous |
| Subject | Midazolam | Small molecule | 0.05 mg/kg | Intravenous |
| Background | Fentanyl | Other / unclassified | — | — |