A Research Study to Evaluate the Effectiveness of Dexmedetomidine in Preventing Delirium After Hip Fracture Repair Surgery

This study has been terminated.
(The incidence of post-operative delirium observed from interim blinded data was significantly lower than the current literature in this population.)
Sponsor:
Information provided by:
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT00460473
First received: April 13, 2007
Last updated: November 9, 2007
Last verified: November 2007
  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.


Condition Intervention Phase
Delirium
Drug: Dexmedetomidine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hospira, Inc.:

Primary Outcome Measures:
  • Postoperative delirium

Secondary Outcome Measures:
  • Duration and percentage of Delirium, amount of sedation and analgesics administered, mortality, length of hospital stay and discharge status

Estimated Enrollment: 310
Study Start Date: April 2007
Study Completion Date: November 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hip fracture repair surgery within 72 hours of hospital admission
  • Female subject not pregnant or lactating
  • ASA I, II, III, IV

Exclusion Criteria:

  • MMSE of ≤ 20
  • Positive CAM-ICU
  • Chronic Antipsychotic therapy
  • Multiple surgeries within the 72 hours prior to study drug infusion and 3 day follow-up period.
  • Anticipated to require repair of a pelvic fracture.
  • Has participated in another clinical trial within 30 days
  • Liver failure
  • Increased intracranial pressure, uncontrolled seizures, psychiatric disorder
  • Received treatment with an alpha 2 agonist or antagonist within 14 days
  • Considered currently to be abusing drugs
  • Experiencing acute unstable angina, acute myocardial infarction, HR<50bpm, SBP< 90mmHg, or third degree heart block, unless has pacemaker
  • Life expectancy less than 60 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00460473

  Show 29 Study Locations
Sponsors and Collaborators
Hospira, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00460473     History of Changes
Other Study ID Numbers: DEX-06-09
Study First Received: April 13, 2007
Last Updated: November 9, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Hospira, Inc.:
Mental Health
Neurological Disease
Hip Injuries and Disorders

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014