Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00460473
Status:
TERMINATED
Last Update Posted:
2015-07-24
First Post:
2007-04-13
Brief Title:
A Research Study to Evaluate the Effectiveness of Dexmedetomidine in Preventing Delirium After Hip Fracture Repair Surgery
Sponsor:
Hospira now a wholly owned subsidiary of Pfizer
Organization:
Hospira now a wholly owned subsidiary of Pfizer
Study Overview
Official Title:
A Phase IIIRandomized 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
Status:
TERMINATED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The incidence of post-operative delirium observed from interim blinded data was significantly lower than the current literature in this population
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of perioperative use of dexmedetomidine in the prevention of postoperative delirium in subjects undergoing surgery for fractured hip with general anesthesia
Detailed Description:
Postoperative delirium is an acute decline in cognition and attention which is usually transient but when delirium persists it can impact cognitive function morbidity and morality There are no drugs that are currently approved to prevent the onset of delirium but dexmedetomidine has the potential to meet this unmet medical need Hip fractures unfortunately are frequent occurrences in the elderly population and the elderly are more prone to developing delirium after surgery
Dexmedetomidine is currently approved for use for 24 hours in patients on ventilators in the ICU 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 At discharge patients resource utilization will be evaluated and thirty days after surgery questions will be asked regarding quality of life
Dexmedetomidine is currently approved for use for 24 hours in patients on ventilators in the ICU 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 At discharge patients resource utilization will be evaluated and thirty days after surgery questions will be asked regarding quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None