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

Delirium Clinical Trial

Official title:

ICU Delirium: Can Dexmedetomidine Reduce Its Incidence?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00417664
• Other study ID #: 77815
• Status: Completed
• Start date: April 2002
• Est. completion date: April 2004

Study information

• Verified date: May 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium

Intervention

Drug:
• Dexmedetomidine
Dexmedetomidine administered as part of anesthesia in cardiac surgery patients
• Propofol
Propofol administered as part of anesthesia in cardiac surgery patients
• Midazolam
Midazolam administered as part of anesthesia in cardiac surgery patients

Locations

Country	Name	City	State
United States	Stanford University Medical Center	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Delirium (DSM-IV criteria)
Secondary	Length of Stay (hospital and ICU), use of as needed medications