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.)
Information provided by (Responsible Party):
Hospira, Inc.
ClinicalTrials.gov Identifier:
First received: April 13, 2007
Last updated: July 23, 2015
Last verified: July 2015

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.

Condition Intervention Phase
Drug: Dexmedetomidine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
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:
  • Percentage of subjects who experienced any postoperative delirium up to 3 days after the end of study drug infusion [ Time Frame: Twice daily (between 6:00-9:00 AM and 5:00-8:00 PM) until 3 days after the end of study drug infusion. ] [ Designated as safety issue: No ]
    The presence of postoperative delirium will be determined by Confusion Assessment Method for the Intensive Care Unit (CAM-ICU).

Secondary Outcome Measures:
  • Duration of postoperative delirium as determined by CAM-ICU up to 3 days after end of study drug infusion [ Time Frame: Twice daily (between 6:00-9:00 AM and 5:00-8:00 PM) until 3 days after the end of study drug infusion. ] [ Designated as safety issue: No ]
  • Percentage of subjects who experienced postoperative delirium each day after end of study drug infusion [ Time Frame: Twice daily (between 6:00-9:00 AM and 5:00-8:00 PM) until 3 days after the end of study drug infusion. ] [ Designated as safety issue: No ]
  • Perioperative use of all analgesics (Fentanyl, Morphine, and oral analgesics) [ Time Frame: During the intraoperative period, Post-anesthesia care unit period and the 3 days Follow-up Period. ] [ Designated as safety issue: No ]
  • Postoperative use of Midazolam [ Time Frame: During the PACU period (Approximately 2 hours) ] [ Designated as safety issue: No ]

    If RASS >0, midazolam (MDZ) 0.5-1 mg IV will be given until RASS <0. While in PACU during study drug infusion period, MDZ (0.5-1 mg IV) will be given if RASS >+1 under allowed maximum dose of study drug.

    RASS range:

    • +4 Combative -Overtly combative, violent, immediate danger to staff
    • +3 Very agitated- Pulls or removes tubes or catheters, aggressive
    • +2 Agitated- Frequent non-purposeful movements, fights ventilator
    • +1 Restless- Anxious, but movements not aggressive or vigorous
    • 0 Alert and calm
    • -1 Drowsy - Not fully alert, but sustained awakening (eye opening, eye contact) to voice (>10 sec)
    • -2 Light sedation - Briefly awakens with eye contact to voice (<10 sec)
    • -3 Moderate sedation - Movement or eye opening to voice (but no eye contact)
    • -4 Deep sedation No response to voice, but movement or eye opening to physical stimulation
    • -5 Unarousable No response to voice or physical stimulation

  • Time-to-Aldrete score of ≥9 [ Time Frame: Every 15±5 minutes from arrival in the PACU (Approximately 2 hours) ] [ Designated as safety issue: No ]
    A score of 9-10 indicates the subject has recovered from anesthesia and is ready for discharge from the PACU.

  • Length of post-operative hospital stay [ Time Frame: From the post operative period until subject discharged from hospital ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: April 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexmedetomidine Drug: Dexmedetomidine
Placebo Comparator: Placebo (PBO) Drug: Placebo

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 patient's resource utilization will be evaluated and thirty days after surgery questions will be asked regarding quality of life.


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

Inclusion Criteria:

  1. Adult (≥18 years old) male or female who will undergo surgery for fractured hip with general anesthesia within 72 hours of admission to hospital.
  2. If female, subject is non-lactating and is either:

    1. Not of childbearing potential, defined as post-menopausal for at least 1 year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy or hysterectomy.
    2. Of childbearing potential but is not pregnant at time of baseline and is practicing one of the following methods of birth control: oral or parenteral contraceptives, double-barrier method, vasectomized partner, or abstinence from sexual intercourse.
  3. Subject is American Society of Anesthesiologists Physical Status I, II, III, or IV.
  4. Subject (or subject's legally authorized representative) has voluntarily signed and dated the informed consent document approved by the Institutional Review Board (IRB).

Exclusion Criteria:

  1. Cognitive function level by Mini Mental State Exam (MMSE) of ≤20.
  2. Subject has a positive CAM-ICU result for delirium at Screening or Baseline.
  3. Subject requires chronic antipsychotic therapy.
  4. Subject is anticipated to require additional surgical procedures during the 72 hour Screening Period and the 3 days Follow-up Period.
  5. Subject is anticipated to require repair of pelvic fractures (eg,acetabulum).
  6. Subject has participated in a trial with any experimental drug or experimental implantable device within 30 days prior to the study drug administration, or has ever been enrolled in this study.
  7. Subject known to be in liver failure.
  8. Subject has an anticipated potential for increased intracranial pressure or an uncontrolled seizure disorder or known psychiatric illness that could confound a normal response during study assessment.
  9. Subject has received treatment with a α2-agonist or antagonist (within 14 days of study entry).
  10. Subject for whom opiates, benzodiazepines, DEX or other α2-agonists are contraindicated.
  11. Subject has, per the investigator's judgment, a known or suspected physical or psychological dependence on an abused drug, other than alcohol.
  12. Subject has acute unstable angina, acute myocardial infarction, HR <50 bpm, SBP <90 mmHg, or third degree heart block unless the subject has a pacemaker.
  13. Subject has any condition or factor which, in the Investigator's opinion, might increase the risk to the subject.
  14. Subject is not expected to live more than 60 days.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00460473

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Sponsors and Collaborators
Hospira, Inc.
  More Information

No publications provided

Responsible Party: Hospira, Inc.
ClinicalTrials.gov Identifier: NCT00460473     History of Changes
Other Study ID Numbers: DEX-06-09
Study First Received: April 13, 2007
Last Updated: July 23, 2015
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, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics, Non-Narcotic
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 09, 2015