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OpenTrials
Completed

NCT Number: NCT00417664

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • Pregnancy

Treatment and study plan

Dexmedetomidine

Drug

Dexmedetomidine administered as part of anesthesia in cardiac surgery patients

Other names: Precedex

Propofol

Drug

Propofol administered as part of anesthesia in cardiac surgery patients

midazolam

Drug

Midazolam administered as part of anesthesia in cardiac surgery patients

Primary outcomes

  1. Postoperative Delirium (DSM-IV criteria)

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Abbott

Registry information

Official study title

ICU Delirium: Can Dexmedetomidine Reduce Its Incidence?

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Jan 4, 2007
Registry last updated
May 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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