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Is Dexmedetomidine Associated With a Lower Incidence of Postoperative Delirium When Compared to Propofol or Midazolam in Cardiac Surgery Patients

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ClinicalTrials.gov Identifier: NCT00417664
Recruitment Status : Unknown
Verified January 2007 by Stanford University.
Recruitment status was:  Active, not recruiting
First Posted : January 4, 2007
Last Update Posted : January 4, 2007
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to determine whether the use of dexmedetomidine, a selective α2-adrenergic receptor agonist with sedative, analgesic, and antinociceptive properties, would be associated with a lower incidence of delirium when compared to propofol and midazolam. We hypothesize that sedation with dexmedetomidine following cardiac surgery with CPB will be associated with a lower incidence of postoperative delirium.

Condition or disease Intervention/treatment Phase
Delirium Drug: dexmedetomidine Drug: midazolam Drug: propofol Phase 4

Detailed Description:

Delirium is the most common psychiatric syndrome found in the general hospital setting. Between 32 - 80% of cardiac surgery patients may experience post-operative delirium. Because failure to recognize delirium leads to increased morbidity and mortality and prolonged hospital stays, there are compelling clinical and financial reasons to improve the identification and treatment of delirium. Dexmedetomidine, a selective alpha2–adrenergic receptor agonist, may be an alternative to current postoperative sedation when it comes to lowering the incidence of delirium.

Comparisons: The use of postoperative (at sternal closure) dexmedetomidine will be compared to current standards of care propofol and midazolam for postoperative sedation.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: ICU Delirium: Can Dexmedetomidine Reduce Its Incidence?
Study Start Date : April 2002
Estimated Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Postoperative Delirium (DSM-IV criteria)

Secondary Outcome Measures :
  1. Length of Stay (hospital and ICU), use of as needed medications

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Diagnosis of a coronary artery disease, cardiac valve disease, or vascular problems requiring elective surgical intervention
  2. Age older than 18 years of age, less than 90 years of age
  3. Fluency in English, and willingness to participate in the study
  4. No history of recent (< 3 months) of alcohol or drug abuse
  5. No pre-operative evidence of heart block
  6. No history of dementia, schizophrenia, or post-traumatic stress disorder

Exclusion Criteria:

  1. A preexisting diagnoses of dementia, schizophrenia, active or recent alcohol or drug abuse/dependence; post-traumatic stress disorder; acute intoxication (i.e., positive urine drug and/or alcohol test at the time of initial evaluation or upon hospitalization for surgery)
  2. Age younger than 18, or older than 89 years of age
  3. Inability to understand enough English to complete required diagnostic testing
  4. Unwillingness to participate in the study
  5. Inability of subject or surrogate to consent.
  6. Pregnancy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00417664


Locations
United States, California
Stanford University Medical Center
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Abbott
Investigators
Principal Investigator: Jose M Maldonado, MD Stanford University
More Information

ClinicalTrials.gov Identifier: NCT00417664     History of Changes
Other Study ID Numbers: 77815
First Posted: January 4, 2007    Key Record Dates
Last Update Posted: January 4, 2007
Last Verified: January 2007

Keywords provided by Stanford University:
cardiac surgery
valvular surgery
delirium
postoperative delirium
cognitive dysfunction
altered mental status

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Propofol
Dexmedetomidine
Midazolam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
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
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents