Study:
A Phase III,Randomized, Double-Blind, Placebo-Controlled, Two-Arm Parallel, Multicenter Study Evaluating the Efficacy and Safety of Dexmedetomidine in the Prevention of Postoperative Delirium in Subjects Undergoing Surgery for Fractured Hip With General Anesthesia
Rationale:
n/a
Purpose:
Dexmedetomidine is currently approved for use for 24 hours in patients on ventilators in the
ICU. This study is to determine whether or not dexmedetomidine can prevent delirium after
hip fracture repair surgery. Study participation will last from within 72 hours of surgery
to 3 days after surgery, continue throughout surgery and up to 2 hours after surgery.
Delirium will be assessed prior to surgery and for 72 hours after surgery. This assessment
will consist of questions to determine memory and thought process. Thirty days after surgery,
questions will be asked regarding quality of life and hospital billing.
Study Status: Terminated
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Delirium |
Drug: Dexmedetomidine |
Phase 3 |
Verified by
Hospira, Inc.
November, 2007
Sponsored by: Hospira, Inc.
Information provided by: Hospira, Inc.
ClinicalTrials.gov identifier: NCT00460473
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
The Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
n/a