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

Phase III Randomized Placebo-controlled Double Blind Comparative Study to Investigate the Efficacy and Safety of DA-9501 in Sedation During the Surgery With Epidural Anesthesia or Spinal Anesthesia Without Intubation Under Monitored Sedation Care

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Phase III, randomized, placebo controlled, double blind, parallel comparative study (Therapeutic confirmatory trial), to evaluate the efficacy and the safety of Dexmedetomidine in non-intubated patients who require sedation during surgery with spinal or epidural anesthesia under monitored sedation care

Conditions

• Sedation

Interventions

Type	Name	Description
DRUG	Dexmedetomidine hydrochloride	Dexmedetomidine 0.2 to 0.7 mcg/kg/hr
DRUG	Placebo

Timeline

• Start date: 2011-06-03
• Primary completion: 2011-11-18
• Completion: 2011-11-18
• First posted: 2011-09-22
• Last updated: 2021-03-22
• Results posted: 2021-03-22

Locations

12 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study