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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Stanford University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Abbott
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00417664
First received: January 3, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  Purpose

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 Intervention Phase
Delirium
Drug: dexmedetomidine
Drug: midazolam
Drug: propofol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: ICU Delirium: Can Dexmedetomidine Reduce Its Incidence?

Resource links provided by NLM:


Further study details as provided by Stanford University:

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

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

Estimated Enrollment: 90
Study Start Date: April 2002
Estimated Study Completion Date: December 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00417664     History of Changes
Other Study ID Numbers: 77815
Study First Received: January 3, 2007
Last Updated: January 3, 2007
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Delirium
Confusion
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Dexmedetomidine
Midazolam
Propofol
Adjuvants, Anesthesia
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Analgesics, Non-Narcotic
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Anti-Anxiety Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on November 25, 2014