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临床试验/NCT00417664
NCT00417664已完成不适用

ICU Delirium: Can Dexmedetomidine Reduce Its Incidence?

Stanford University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2002年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Postoperative Delirium (DSM-IV criteria)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

Dexmedetomidine

干预措施: Dexmedetomidine (Drug)

Propofol

干预措施: Propofol (Drug)

Midazolam

干预措施: Midazolam (Drug)

结局指标

主要结局

Postoperative Delirium (DSM-IV criteria)

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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