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Clinical Trials/NCT00417664
NCT00417664
Completed
Not Applicable

ICU Delirium: Can Dexmedetomidine Reduce Its Incidence?

Stanford University1 site in 1 country90 target enrollmentApril 2002

Overview

Phase
Not Applicable
Intervention
Dexmedetomidine
Conditions
Delirium
Sponsor
Stanford University
Enrollment
90
Locations
1
Primary Endpoint
Postoperative Delirium (DSM-IV criteria)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The purpose of this chart review 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.

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.

Registry
clinicaltrials.gov
Start Date
April 2002
End Date
April 2004
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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)
  • Age younger than 18, or older than 89 years of age
  • Inability to understand enough English to complete required diagnostic testing
  • Unwillingness to participate in the study
  • Inability of subject or surrogate to consent.

Arms & Interventions

Dexmedetomidine

Intervention: Dexmedetomidine

Propofol

Intervention: Propofol

Midazolam

Intervention: Midazolam

Outcomes

Primary Outcomes

Postoperative Delirium (DSM-IV criteria)

Secondary Outcomes

  • Length of Stay (hospital and ICU), use of as needed medications

Study Sites (1)

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