Desflurane or Propofol Anesthesia in Elderly Obese Patients Undergoing Total Knee Replacement: A Pilot Assessment of Short-term and Long-term Differences in Outcome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Recall of Digit Span
研究概览
简要总结
You are invited to participate in a research study assessing your mental status in the first days after your surgery and how you will be doing in the 2 years following the surgery. The investigators hope to learn more about the incidence of postoperative confusion and a possible relation with 2 anesthesia techniques that are routinely used. The first one is an anesthesia technique that uses the inhaled anesthetic gas desflurane and the second one is an anesthesia technique that uses the anesthetic propofol administered by infusion in a vein. The investigators are also looking to see if there is a relationship between anesthesia technique and cardiovascular outcomes. You were selected as a possible participant in this study because at your age this phenomenon appears to have a greater incidence.
详细描述
Trial Objectives:
This will be a randomized, prospective, single-center, assessor blinded pilot study comparing two different anesthesia techniques in 100 elderly obese patients undergoing primary total knee arthroplasty.
Endpoints:
- The incidence of postoperative delirium as measured by the Confusion Assessment Score. Confusion assessment score will be administered at baseline, one hour after arrival in the post anesthesia care unit and 6-8, 24 and 48 hrs postoperatively.
- Cognitive function as measured by Test for Attentional Performance, Digit-Symbol-Substitution Test, Recal of Digit Span , Well-being Test BF-S, Spielberger State-Trait Anxiety Inventory and the Trail Making Test A and B. Cognitive function tests will be administered at baseline, 6-8 and 48 hrs post operatively. Postoperative Cognitive Dysfunction is defined as a 20% decline of the baseline values.
Intraoperative
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 65 years old
- •Body mass index > 30 kg/m2
- •Undergoing primary total knee arthroplasty surgery
- •American society of anesthesiology classification II-III
排除标准
- •Patient refusal to participate in the study
- •Patient refusal or failure of regional block
- •Patients with preexisting neuro-cognitive disorders
- •Known intolerance to any of the drugs to be used according to the study protocol
研究组 & 干预措施
Desflurane
Patients will receive desflurane as general anesthetics.
干预措施: Desflurane (Drug)
Propofol
Patients will receive propofol as general anesthetics.
干预措施: propofol (Drug)
结局指标
主要结局
Recall of Digit Span
时间窗: Change > 20% from baseline to 48 hours after surgery
• The Digit Span subtest of the Wechsler Adult Intelligence Scale-Revised is a test that requires subjects to repeat a series of digits that have been verbally presented to them both forward and, in a later independent test, reverse order. It measures attention and working memory
Assessment of Delirium
时间窗: 48 hours
The primary end point was the incidence of postoperative delirium as measured by the Confusion Assessment Method (CAM).
Digit Symbol Substitution Test
时间窗: Change > 20% from baseline to 48 hours after surgery
• The Digit Symbol Substitution Test (DSST) measures attention, working memory, sustained visual attention and psychomotor speed. Subjects are given a table that pairs digits and symbols, and asked to decipher a code using the table, completing as many as possible in 90 seconds. The DSST has been found to be more sensitive than other tests to changes in high-levels of cognition
Trail Making Part A
时间窗: Change > 20% from baseline to 48 hours after surgery
• Trail Making Test is an executive measure of sequencing and cognitive flexibility. Trail A requires the subject to rapidly sequence a straightforward series. The scoring for this test is the time in seconds required for completion of the test
Trail Making Part B
时间窗: Change > 20% from baseline to 48 hours after surgery
Trail Making Test is an executive measure of sequencing and cognitive flexibility. Trail B is a more difficult cognitive flexibility task requiring the subject to follow a sequential pattern while shifting cognitive sets and reflects executive functioning, although other cognitive abilities, such as psychomotor speed and visual scanning, are necessary for successful completion of the task. The scoring for this test is the time in seconds required for completion of the test
次要结局
- - Time to Spontaneous Breathing After Desflurane/Propofol Discontinuation(first day)
- - Time to Eye Opening After Desflurane/Propofol Discontinuation(first day)
- - Time to Tracheal Extubation After Desflurane/Propofol Discontinuation(first day)
- - Time to Following Command After Desflurane/Propofol Discontinuation(first day)
- Nausea and Vomiting(48 hours)
- Recovery Room Time(first day)
- B-type Natriuretic Peptide(Change from Baseline to day one)
- Troponin I(2 days)
- N-terminal proBNP(Change from baseline to day one)
- BNP(Change form baseline to post-operative day 2)
- ProBNP(Change from baseline to post-operative day 2)
- Duration of Surgery(Time from Incision to closure of surgery)
- Duration of Anesthesia(Time from induction to extubation)
- Amount of Intraoperative Fentanyl(From the anesthesia induction until extubation)
研究者
Pedro Paulo Tanaka
Clinical Associate Professor
Stanford University