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

NCT ID: NCT00417664

Last Updated: 2022-05-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2002-04-30
• Study Completion Date: 2004-04-30

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.

Conditions

Delirium

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Dexmedetomidine

Dexmedetomidine

Intervention Type: DRUG

Dexmedetomidine administered as part of anesthesia in cardiac surgery patients

Propofol

Propofol

Intervention Type: DRUG

Propofol administered as part of anesthesia in cardiac surgery patients

Midazolam

Midazolam

Intervention Type: DRUG

Midazolam administered as part of anesthesia in cardiac surgery patients

Interventions

Dexmedetomidine

Dexmedetomidine administered as part of anesthesia in cardiac surgery patients

Intervention Type: DRUG

Propofol

Propofol administered as part of anesthesia in cardiac surgery patients

Intervention Type: DRUG

Midazolam

Midazolam administered as part of anesthesia in cardiac surgery patients

Intervention Type: DRUG

Other Intervention Names

Precedex

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose R Maldonado, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University Medical Center

Stanford, California, United States

Countries

United States

Other Identifiers

77815

Identifier Type: -

Identifier Source: org_study_id