DeliriumNCT00417664
Is Dexmedetomidine Associated With a Lower Incidence of Postoperative Delirium When Compared to Propofol or Midazolam in Cardiac Surgery Patients
An observational study of Delirium, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Delirium
- What is being tested?
- Dexmedetomidine, Propofol and Midazolam
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2002to Apr 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cardiac surgery patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Medical Center
Stanford, California, 94305
About this study
Official title: ICU Delirium: Can Dexmedetomidine Reduce Its Incidence?
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.
Read the 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
- Being tested
- Dexmedetomidine, Propofol, Midazolam
- Keywords
- cardiac surgery, valvular surgery, delirium, postoperative delirium, cognitive dysfunction, altered mental status
- Medical subject headings
- Delirium, Emergence Delirium, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
Dexmedetomidine administered as part of anesthesia in cardiac surgery patients
PropofolDrug
Propofol administered as part of anesthesia in cardiac surgery patients
MidazolamDrug
Midazolam administered as part of anesthesia in cardiac surgery patients
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Not described Receives: Drug: Dexmedetomidine | |
| Propofol | Not described Receives: Drug: Propofol | |
| Midazolam | Not described Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Delirium (DSM-IV criteria)
Secondary outcomes (1)
Length of Stay (hospital and ICU), use of as needed medications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2007 (estimated)
- Study startApr 2002
- Primary completionJan 2004
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Jose R Maldonado, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00417664
- Sponsor's protocol ID
- 77815
- Status last verified
- May 2022
- First submitted
- 3 Jan 2007
- Last updated
- 27 May 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICU Delirium: Can Dexmedetomidine Reduce Its Incidence?
- ClinicalTrials.gov ID
- NCT00417664
- Acronym / sponsor ID
- 77815
- Conditions
- Delirium
- Keywords
- cardiac surgery, valvular surgery, delirium, postoperative delirium, cognitive dysfunction, altered mental status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Apr 2002
- Primary completion
- Jan 2004 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 4 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | – | Drug: Dexmedetomidine |
| Propofol | – | Drug: Propofol |
| Midazolam | – | Drug: Midazolam |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiac surgery patients
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: PrecedexDexmedetomidine administered as part of anesthesia in cardiac surgery patients | Drug | Dexmedetomidine |
| PropofolPropofol administered as part of anesthesia in cardiac surgery patients | Drug | Propofol |
| MidazolamMidazolam administered as part of anesthesia in cardiac surgery patients | Drug | Midazolam |
Primary outcome
Postoperative Delirium (DSM-IV criteria)
1 secondary outcome
Length of Stay (hospital and ICU), use of as needed medications
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
Related trials for Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
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Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
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DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose R Maldonado, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Delirium (DSM-IV criteria). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.