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

Sponsors and Collaborators:	Stanford University Abbott
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00417664

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 IV

MedlinePlus related topics: Heart Surgery

Drug Information available for: Midazolam Midazolam hydrochloride Midazolam maleate Propofol Dexmedetomidine Dexmedetomidine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	ICU Delirium: Can Dexmedetomidine Reduce Its Incidence?

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:

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

Contacts and Locations

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

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

Keywords provided by Stanford University:

cardiac surgery
valvular surgery
delirium

postoperative delirium
cognitive dysfunction
altered mental status

Study placed in the following topic categories:

Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Neurologic Manifestations
Confusion
Dexmedetomidine

Propofol
Midazolam
Dementia
Neurobehavioral Manifestations
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Anesthetics
Adrenergic Agonists
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Analgesics
Anesthetics, Intravenous

Tranquilizing Agents
Adrenergic alpha-Agonists
Nervous System Diseases
Central Nervous System Depressants
Pharmacologic Actions
Adjuvants, Anesthesia
Anesthetics, General
Analgesics, Non-Narcotic
GABA Agents
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009