A Randomized, Controlled Trial Reviewing the Effectiveness of a Preventative Delirium Protocol in Elderly Patients While Analyzing Its Consequential Effects on Awareness, PONV, and/or Pain Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 263
- 试验地点
- 1
- 主要终点
- Presence or absence of Delirium (CAM_ICU)
研究概览
简要总结
The current study aims to elucidate the effectiveness of a preventative delirium protocol in patients older than 65 years of age undergoing elective surgery.
详细描述
A comprehensive analysis of patient specific risk factors and predisposing perioperative risk factors will be completed. The objective is to see if delirium incidences are significantly lower in the group that receives a preventative delirium protocol compared to a control group, while not increasing other adverse undesirable side effects. We hypothesize that a preventative delirium protocol will reduce the incidence of delirium compared to the control group (primary outcome), but this protocol may lead to increased side effects such as PONV, poor pain control, and increased awareness (secondary outcomes).
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
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 89 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 65 years
- •Scheduled for Elective Surgery (outpatient/same-day admit)
排除标准
- •Need emergency surgery
- •Need intracranial surgery
- •Dependent on opiate narcotics
- •Surgeon-specified perioperative procedures that precludes the current study's protocol
研究组 & 干预措施
Control
Subjects will receive anesthesia
干预措施: Control (Other)
Preventative Delirium Protocol
-
Consider regional block if applicable
-
Minimized fentanyl usage intraoperatively
-
Intubation + GA adjunct total: 1-2 mcg/kg
-
Sedation: 0-0.25 mcg/kg
-
Post-op: 0.5-1 mcg/kg
-
Avoid morphine
-
Avoid ketamine
-
Avoid diphenhydramine, dexamethasone, scopolamine, metoclopramide, and promethazine
-
Avoid H2-blockers (cimetidine, ranitidine, famotidine)
-
Avoid polypharmacy intraoperatively if possible (i.e. >5 new medications)
-
Fluid repletion based on maintenance and losses
干预措施: Preventative Delirium Protocol (Other)
结局指标
主要结局
Presence or absence of Delirium (CAM_ICU)
时间窗: Within one post-operative day
Delirium defined by Post-operative CAM, using the validated CAM-ICU measure
次要结局
- NRS Pain(Within one post-operative day)
- PONV(Within one post-operative day)
研究者
Asokumar Buvanendran
Professor of Anesthesiology
Rush University Medical Center