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

NCT00417664 | Completed FDA Drug

• 1 other identifier: 77815
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Keywords

cardiac surgery; valvular surgery; delirium; postoperative delirium; cognitive dysfunction; altered mental status

Outcome Measures

Primary Outcomes (1)

• Postoperative Delirium (DSM-IV criteria)

Secondary Outcomes (1)

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

Study Arms (3)

Dexmedetomidine

Drug: Dexmedetomidine

Propofol

Drug: Propofol

Midazolam

Drug: Midazolam

Interventions

Dexmedetomidine DRUG

Dexmedetomidine administered as part of anesthesia in cardiac surgery patients

Also known as: Precedex

Dexmedetomidine

Propofol DRUG

Propofol administered as part of anesthesia in cardiac surgery patients

Propofol

Midazolam DRUG

Midazolam administered as part of anesthesia in cardiac surgery patients

Midazolam

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cardiac surgery patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• Abbott: collaborator

Study Sites (1)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Delirium; Emergence Delirium; Cognitive Dysfunction

Interventions

Dexmedetomidine; Propofol; Midazolam

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Postoperative Complications; Pathologic Processes; Cognition Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jose R Maldonado, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2007
• First Posted: January 4, 2007
• Study Start: April 1, 2002
• Primary Completion: January 1, 2004
• Study Completion: April 1, 2004
• Last Updated: May 27, 2022

Record last verified: 2022-05

Locations

US (1)