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

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.

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.