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

NCT00460473 | Terminated Phase 3

• 1 other identifier: DEX-06-09
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 30

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.

Conditions

Delirium

Keywords

Mental Health; Neurological Disease; Hip Injuries and Disorders

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (6)

• 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.

• 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.

• 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.

• Postoperative use of Midazolam

  During the PACU period (Approximately 2 hours)

• Time-to-Aldrete score of ≥9

  Every 15±5 minutes from arrival in the PACU (Approximately 2 hours)

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

Drug: Dexmedetomidine

Placebo (PBO)

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Dexmedetomidine DRUG

Dexmedetomidine

Placebo DRUG

Placebo (PBO)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (≥18 years old) male or female who will undergo surgery for fractured hip with general anesthesia within 72 hours of admission to hospital.
• If female, subject is non-lactating and is either:
• 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.
• 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.
• Subject is American Society of Anesthesiologists Physical Status I, II, III, or IV.
• Subject (or subject's legally authorized representative) has voluntarily signed and dated the informed consent document approved by the Institutional Review Board (IRB).

You may not qualify if:

• Cognitive function level by Mini Mental State Exam (MMSE) of ≤20.
• Subject has a positive CAM-ICU result for delirium at Screening or Baseline.
• Subject requires chronic antipsychotic therapy.
• Subject is anticipated to require additional surgical procedures during the 72 hour Screening Period and the 3 days Follow-up Period.
• Subject is anticipated to require repair of pelvic fractures (eg,acetabulum).
• 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.
• Subject known to be in liver failure.
• 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.
• Subject has received treatment with a α2-agonist or antagonist (within 14 days of study entry).
• Subject for whom opiates, benzodiazepines, DEX or other α2-agonists are contraindicated.
• Subject has, per the investigator's judgment, a known or suspected physical or psychological dependence on an abused drug, other than alcohol.
• 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.
• Subject has any condition or factor which, in the Investigator's opinion, might increase the risk to the subject.
• Subject is not expected to live more than 60 days.

Sponsors & Collaborators

• Hospira, now a wholly owned subsidiary of Pfizer: lead

Study Sites (30)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

LAC-USC Medical Center Los Angeles

Los Angeles, California, 90033, United States

Location

Huntington Memorial Hospital

Pasadena, California, 91105, United States

Location

University of Miami-Jackson Memorial Medical Center

Miami, Florida, 33101, United States

Location

Southeastern Clinical Research Consultants

Orlando, Florida, 32804, United States

Location

Orlando Regional Healthcare, Critical Care Medicine

Orlando, Florida, 32806, United States

Location

G and G Research, Inc.

Vero Beach, Florida, 32960, United States

Location

Orthopaedic Center of Vero Beach

Vero Beach, Florida, 32960, United States

Location

Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

University of Iowa Hospitals and Clinics, Dept. of Anesthesia

Iowa City, Iowa, 52242-1053, United States

Location

Outcomes Research Institute

Louisville, Kentucky, 40202, United States

Location

Louisiana State University, Dept. of Orthopaedic Surgery

Shreveport, Louisiana, 71103, United States

Location

Spectrum Health Blodgett Campus

Grand Rapids, Michigan, 49506-2810, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Saint Mary's Duluth Clinic Health System

Duluth, Minnesota, 55805, United States

Location

Mayo Clinic College of Medicine, Dept. of Anesthesiology

Rochester, Minnesota, 55906, United States

Location

University of Missouri

Columbia, Missouri, 65212, United States

Location

Mount Sinai School of Medicine

Great Neck, New York, 11021, United States

Location

New York University Medical Center

New York, New York, 10016, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

University of Pittsburgh Medical Center, Presbyterian

Pittsburgh, Pennsylvania, 15213-2582, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Research Concepts

Bellaire, Texas, 77401, United States

Location

Parkland Health and Hospital System

Dallas, Texas, 75390-9179, United States

Location

University of Virginia Health Systems

Charlottesville, Virginia, 22908-0710, United States

Location

University of Wisconsin Medical School, Dept. of Anesthesiology

Madison, Wisconsin, 53792, United States

Location

VA Medical Center

Milwaukee, Wisconsin, 53295, United States

Location

MeSH Terms

Conditions

Delirium; Psychological Well-Being; Nervous System Diseases; Hip Injuries; Disease

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Personal Satisfaction; Behavior; Wounds and Injuries; Pathologic Processes

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2007
• First Posted: April 16, 2007
• Study Start: April 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: July 24, 2015

Record last verified: 2015-07

Locations

US (30)