Is Dexmedetomidine Associated With a Lower Incidence of Postoperative Delirium When Compared to Propofol or Midazolam in Cardiac Surgery Patients
ICU Delirium: Can Dexmedetomidine Reduce Its Incidence?
研究概览
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
California
-
Stanford、California、美国、94305
- Stanford University Medical Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
异丙酚
|
Propofol administered as part of anesthesia in cardiac surgery patients
|
|
Dexmedetomidine
|
Dexmedetomidine administered as part of anesthesia in cardiac surgery patients
其他名称:
|
|
Midazolam
|
Midazolam administered as part of anesthesia in cardiac surgery patients
|
研究衡量的是什么?
主要结果指标
结果测量 |
|---|
|
Postoperative Delirium (DSM-IV criteria)
|
次要结果测量
结果测量 |
|---|
|
Length of Stay (hospital and ICU), use of as needed medications
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 77815
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.