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

Delirium Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00460473
• Other study ID #: DEX-06-09
• Status: Terminated
• Phase: Phase 3
• First received: April 13, 2007
• Last updated: July 23, 2015
• Start date: April 2007
• Est. completion date: November 2007

Study information

• Verified date: July 2015
• Source: Hospira, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 a2-agonist or antagonist (within 14 days of study entry).

10. Subject for whom opiates, benzodiazepines, DEX or other a2-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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Delirium

Intervention

Drug:
• Dexmedetomidine

• Placebo

Locations

Country	Name	City	State
United States	Medical College of Georgia	Augusta	Georgia
United States	Research Concepts	Bellaire	Texas
United States	University of Virginia Health Systems	Charlottesville	Virginia
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	University of Missouri	Columbia	Missouri
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Parkland Health and Hospital System	Dallas	Texas
United States	Saint Mary's Duluth Clinic Health System	Duluth	Minnesota
United States	Duke University Medical Center	Durham	North Carolina
United States	Spectrum Health Blodgett Campus	Grand Rapids	Michigan
United States	Mount Sinai School of Medicine	Great Neck	New York
United States	University of Iowa Hospitals and Clinics, Dept. of Anesthesia	Iowa City	Iowa
United States	Loma Linda University Medical Center	Loma Linda	California
United States	LAC-USC Medical Center Los Angeles	Los Angeles	California
United States	Outcomes Research Institute	Louisville	Kentucky
United States	University of Wisconsin Medical School, Dept. of Anesthesiology	Madison	Wisconsin
United States	University of Miami-Jackson Memorial Medical Center	Miami	Florida
United States	VA Medical Center	Milwaukee	Wisconsin
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	New York University Medical Center	New York	New York
United States	Orlando Regional Healthcare, Critical Care Medicine	Orlando	Florida
United States	Southeastern Clinical Research Consultants	Orlando	Florida
United States	Huntington Memorial Hospital	Pasadena	California
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center, Presbyterian	Pittsburgh	Pennsylvania
United States	Mayo Clinic College of Medicine, Dept. of Anesthesiology	Rochester	Minnesota
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Louisiana State University, Dept. of Orthopaedic Surgery	Shreveport	Louisiana
United States	G and G Research, Inc.	Vero Beach	Florida
United States	Orthopaedic Center of Vero Beach	Vero Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Hospira, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects who experienced any postoperative delirium up to 3 days after the end of study drug infusion	The presence of postoperative delirium will be determined by Confusion Assessment Method for the Intensive Care Unit (CAM-ICU).	Twice daily (between 6:00-9:00 AM and 5:00-8:00 PM) until 3 days after the end of study drug infusion.	No
Secondary	Duration of postoperative delirium as determined by CAM-ICU up to 3 days after end of study drug infusion		Twice daily (between 6:00-9:00 AM and 5:00-8:00 PM) until 3 days after the end of study drug infusion.	No
Secondary	Percentage of subjects who experienced postoperative delirium each day after end of study drug infusion		Twice daily (between 6:00-9:00 AM and 5:00-8:00 PM) until 3 days after the end of study drug infusion.	No
Secondary	Perioperative use of all analgesics (Fentanyl, Morphine, and oral analgesics)		During the intraoperative period, Post-anesthesia care unit period and the 3 days Follow-up Period.	No
Secondary	Postoperative use of Midazolam	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	During the PACU period (Approximately 2 hours)	No
Secondary	Time-to-Aldrete score of =9	A score of 9-10 indicates the subject has recovered from anesthesia and is ready for discharge from the PACU.	Every 15±5 minutes from arrival in the PACU (Approximately 2 hours)	No
Secondary	Length of post-operative hospital stay		From the post operative period until subject discharged from hospital	No