Intravenous General Anesthesia Versus Inhalational General Anesthesia in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Number of Participants With Improved Postoperative Delirium and Cognitive and Motor Changes
研究概览
简要总结
Parkinson's disease is a common progressive degenerative disease affecting 3% of all patients over the age of 65. Given their age and frailty, these patients frequently require surgical procedures with general anesthesia. However, after surgery, patients with Parkinson's disease have longer hospital stays and a greater chance of not returning to independent living compared to age-matched controls (Berman MF, unpublished data). In part, this is due to a higher rate of post-operative delirium, which had an incidence of 60% in this population in one study. There is anecdotal evidence from neurologists specializing in movement disorder suggesting that there is also significant deterioration in parkinsonian motor symptoms and cognition lasting for months or years following surgery and anesthesia. The basis for this deterioration is unknown. We hypothesize that these problems are caused by particular medications used during inhaled anesthesia for surgical procedures.
详细描述
We will compare the groups in terms of postoperative delirium, and cognitive and motor function changes. Patients randomized to an inhaled anesthetic will receive a standard anesthetic mix: an inhaled anesthetic with intravenous agents for rapid induction of anesthesia, narcotics for postoperative pain relief, and muscle relaxation. Patients randomized to IV anesthesia will receive a continuous infusion of propofol and remifentanil (ultrashort acting narcotic) instead of the inhalation anesthetics during the maintenance phase of the anesthetic. Other components of the anesthetic will be the same as in the "inhaled anesthetic" group.
We hypothesize that:
- Patients with Parkinson's disease will have less postoperative delirium and less prolonged cognitive and motor changes after total intravenous anesthesia than following inhaled anesthesia.
- Apolipoprotein E4 (Apo E4) allele will be associated with postoperative cognitive dysfunction in Parkinsonian patients
To test our hypotheses we will:
- Randomize patients with Parkinson's disease having surgery for implantation of current generator for subthalamic stimulator to receive either a total intravenous anesthetic or an inhaled anesthetic.
- Compare these two groups of patients for incidence of postoperative delirium and the degree of postoperative cognitive and motor dysfunction.
- Test for an association between the (Apo E4) allele and postoperative cognitive change. A buccal sampling or cheek cell sampling method will be employed to obtain DNA for genotyping of the Apo E allele.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Parkinson's Disease with bilateral deep brain stimulation surgery indicated as treatment
排除标准
- •Not fluent in English
研究组 & 干预措施
Group 1
Inhaled Anesthesia - isoflurane
干预措施: Isoflurane (Drug)
Group 2
Intravenous Anesthesia - propofol, remifentanil
干预措施: Remifentanil (Drug)
Group 2
Intravenous Anesthesia - propofol, remifentanil
干预措施: Propofol (Drug)
结局指标
主要结局
Number of Participants With Improved Postoperative Delirium and Cognitive and Motor Changes
时间窗: Four months
A battery/Questionnaire of neuropsych examinations is given to the subjects to measure improvement based on change of scores and standard deviation. The battery consists of questions regarding delirium, cognitive and motor changes and yields a combination assessment of all 3 elements.
次要结局
未报告次要终点
研究者
Eric J. Heyer, MD, PhD
Professor of Clinical Anesthesiology
Columbia University