drugset / Trial / NCT01438957

Clinical Study to Investigate the Efficacy and the Safety of DA-9501 in Sedation During the Surgery With Epidural Anesthesia or Spinal Anesthesia Without Intubation

NCT01438957

Phase 3 Completed 119 enrolled Pfizer Maruishi Pharmaceutical · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to examine the efficacy and safety of DA-9501 (Dexmedetomidine) in patients who require sedation during the surgery that requires epidural or spinal anesthesia without intubation under monitored sedation care.

Timeline

Start
2011-06-03
Primary completion
2011-11-18
Completion
2011-11-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 0.067 ug/kg Intravenous
Subject Dexmedetomidine Other / unclassified 0.25 ug/kg Intravenous
Subject Dexmedetomidine Other / unclassified 0.5 ug/kg Intravenous
Subject Dexmedetomidine Other / unclassified 1 ug/kg Intravenous

Indications

No indication recorded.