An Examination of the Effects of Modafinil (Provigil) or Placebo on Neurocognitive Testing After General Anesthesia for Non-Cardiac Surgery in an Older Population
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 137
- 主要终点
- Rey Auditory Verbal Learning Test (RAVLT) scores
研究概览
简要总结
Postoperative cognitive dysfunction is a well-recognized complication of surgery. The aim of the study is to investigate whether cognitive dysfunction is reduced by the use of modafinil as shown by neurocognitive testing.The treatment effects will be evaluated compared to placebo as well as a non-surgical group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 99 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists class I or II
- •Elective surgery
- •Surgery requiring general anesthesia
- •4.) Control Group will be-females & males 65 and older not scheduled for any surgical procedures for at least a 3 month period.
排除标准
- •Neurosurgery
- •Cardiac surgery
- •Narcotic or illicit drug abuse
- •Chronic opioid use
- •Chronic use of anxiolytics
- •History of pulmonary disease
- •C02 retention
- •Sleep apnea
研究组 & 干预措施
Preoperative modafinil + postoperative placebo
干预措施: Preoperative modafinil + postoperative placebo (Drug)
Preoperative modafinil + postoperative modafinil
干预措施: Preoperative modafinil + postoperative modafinil (Drug)
Preoperative placebo + postoperative placebo
干预措施: Preoperative placebo + postoperative placebo (Drug)
结局指标
主要结局
Rey Auditory Verbal Learning Test (RAVLT) scores
时间窗: 3 months
Rey Auditory Verbal Learning Test (RAVLT) scores will be used to assess memory and learning ability in the auditory-verbal domain. The RAVLT begins with a list of 15 words, which an examiner reads aloud at the rate of one per second. The patient's task is to repeat all the words he or she can remember, in any order. This procedure is carried out a total of five times. Then, the examiner presents a second list of 15 words, allowing the patient only one attempt at recall. Immediately following this, the patient is asked to remember as many words as possible from the first list. For each trial a maximum score of 15 can be obtained, which would reflect excellent memory. The obtained scores per individual trial will be compared between the 4 different arms. The RAVLT will be administered preoperatively, immediately postoperatively in the PACU (except the non-surgical control group), at 1 week and at 3 months postoperatively.
次要结局
未报告次要终点
研究者
Ronak Desai, DO
Director, Division of Regional Anesthesia
The Cooper Health System