Perioperative Cognitive Function - Dexmedetomidine and Cognitive Reserve
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 404
- 试验地点
- 10
- 主要终点
- Delirium Battery
研究概览
简要总结
Elderly patients who undergo anesthesia and non-cardiac surgery are subject to deterioration of brain function including the development of postoperative delirium (PD) and postoperative cognitive dysfunction (POCD). These disorders cause disability, distress for both patients and their families, are associated with other medical complications and account for significant additional health care costs. We currently use relatively primitive approaches to preventing and treating PD and POCD.
Dexmedetomidine is a drug used for sedation in critically ill patients that provides some pain relief and controls the bodies response to stress. The sedation produced by dexmedetomidine appears more similar to natural sleep than any other drug used for anesthesia and postoperative sedation. Data suggesting that dexmedetomidine can prevent delirium following cardiac surgery and the developing understanding of the causes of PD and POCD suggest that dexmedetomidine will be particularly effective.
详细描述
Postoperative Delirium or PD and Postoperative Cognitive Dysfunction or POCD are syndromes of central nervous system dysfunction that significantly complicate the recovery of a proportion of elderly patients following surgery.
Delirium is typically a transient syndrome characterized by a de-novo appearance of several pathognomonic behaviors, including disorientation, decreased attention span, sensory misperceptions, a waxing-and-waning type of confusion, and disorganized thinking. PD typically occurs on postoperative days 1 to 3 and is associated with prolonged hospital stays, increased risks for morbidity and mortality and significant health care expenditures.
The neuroendocrine stress response to surgery, including the immediate postoperative period, remains an important potential etiologic factor. In particular, our data suggests that stress in the immediate postoperative period is poorly controlled by all anesthetic techniques and the normal diurnal variation in cortisol is suppressed in subjects who develop POCD.
Dexmedetomidine is a highly selective alpha 2A agonist currently approved for sedation in the ICU. Dexmedetomidine produces analgesia, sympatholysis, and a light sedation characterized by easy arousal. Its action converges on the endogenous substrates for natural sleep to produce their sedative action, an effect that could prove beneficial to elderly postoperative patients.
We hypothesize that treatment with dexmedetomidine will diminish both PD and POCD. The essential proposition is that modulation of perioperative stress can ameliorate perioperative delirium and cognitive dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 68 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •68 and older
- •elective major surgery under general anesthesia(major surgery is defined by a planned 2 day hospitalization)
- •ASA physical status I-III
- •capable and willing to consent
- •MMSE > 20 (to exclude dementia)
排除标准
- •Cardiac surgery
- •Intracranial Surgery
- •Emergency Surgery
- •Patients with severe visual or auditory disorder/handicaps
- •Illiteracy
- •Patients with clinically significant Parkinson's Disease
- •Patients not expected to be able to complete the 3 and 6 month postoperative tests
- •Sick sinus syndrome without pacemaker
- •Hypersensitivity to drug or class
- •Current 2nd or 3rd degree AV block
- •History of clinically significant bradycardia
- •Contraindication to the use of an 2A-agonist
- •Presence of a major psychiatric condition such as bipolar disorder, major depression, schizophrenia, or dementia
- •ASA physical status IV or V
研究组 & 干预措施
Precedex
Precedex (Dexmedetomidine)
干预措施: Precedex (Dexmedetomidine) (Drug)
Placebo
Placebo - normal saline
干预措施: Placebo (Drug)
结局指标
主要结局
Delirium Battery
时间窗: Day 1
Number of Participants with occurrence of Post-Operative Delirium in Post-Anesthesia Care Unit (PACU)
次要结局
- Neuropsychological Testing(at 3 months postoperatively)
- Intraoperative Hypertension(day 1)
- Intraoperative Bradycardia(day 1)
- Length of Stay(average 4 days)
- Intraoperative Hypotension(day 1)
研究者
Stacie Deiner
Associate Professor
Icahn School of Medicine at Mount Sinai