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

PHASE3CompletedINTERVENTIONAL
Enrollment

119

Participants

Timeline

Start Date

June 3, 2011

Primary Completion Date

November 18, 2011

Study Completion Date

November 18, 2011

Conditions
Sedation
Interventions
DRUG

Dexmedetomidine hydrochloride

Dexmedetomidine 0.2 to 0.7 mcg/kg/hr

DRUG

Placebo

Trial Locations (12)

Unknown

Nagoya University Hospital, Nagoya

Asahikawa Medical University Hospital, Asahikawa

Sapporo Medical University Hospital, Sapporo

Kochi Medical School Hospital, Nangoku

Shinshul University Hospital, Matsumoto

Shimane University Hospital, Izumo

Tottori University Hospital, Yonago

Japanese Red Cross Kyoto Daini Hospital, Kyoto

University of Miyazaki Hospital, Miyazaki

Okayama University Hospital, Okayama

Kitano Hospital, The Tazuke Kofukai Medical Research Institute, Osaka

Nippon Medical University Hospital, Tokyo

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Maruishi Pharmaceutical

INDUSTRY

lead

Pfizer

INDUSTRY

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 | Biotech Hunter | Biotech Hunter