Caffeine and Neurologic Recovery Following Surgery and General Anesthesia
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Cumulative Opioid Consumption: Postoperative Opioid Consumption, Oral Morphine Equivalents (mg)
研究概览
简要总结
The ongoing opioid epidemic is a public health crisis, and surgical patients are particularly vulnerable to opioid-dependency and related risks. Emerging data suggest that caffeine may reduce pain after surgery. Thus, the purpose of this study is to test whether caffeine reduces pain and opioid requirements after surgery. The investigators will also test whether caffeine improves mood and brain function (e.g., learning, memory) after surgery.
详细描述
Opioid-related deaths have quadrupled in the last 20 years, and nearly half of these deaths currently involve prescription opioids. Surgical patients often experience moderate-to-severe pain is common after major surgery, and surgery is associated with a 14-fold increased risk of opioid dependency compared to non-surgical controls, even after minor surgery. Furthermore, mood disorders (e.g., depression) are independently associated with persistent opioid use postoperatively, and signs of postoperative depression are common after major surgery. Thus, given these risk factors, surgical patients are at particularly high risk for opioid dependency postoperatively. Interventions that (1) reduce opioid burden, and (2) improve mood and neuropsychological function may mitigate the risk of postoperative opioid dependency. Preliminary laboratory and clinical findings demonstrate that caffeine may reduce pain after surgery, which may translate to lower opioid requirements. The study tests the hypothesis that intraoperative caffeine administration will improve opioid consumption, pain, and neuropsychological recovery in patients undergoing surgery. Through validated assessment measures, the research team will study the effects of caffeine in relation to postoperative opioid requirements, pain, and neuropsychological (e.g., cognition, depression, anxiety) trajectory after surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This will be a single-center, quadruple-blinded, pilot randomized controlled trial at the University of Michigan Health System.
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
- •Adult (>/= 18 years old) undergoing non-cardiac, non-neurologic, non-major vascular surgery requiring general anesthesia
排除标准
- •Emergency surgery
- •Cognitive impairment precluding capacity for informed consent
- •Uncontrolled cardiac arrhythmias
- •Seizure disorders
- •Preoperative opioid use
- •Liver failure
- •Pregnancy
- •Breastfeeding
- •Severe visual or auditory impairment (may hinder cognitive function testing)
- •Patients unable to speak English.
研究组 & 干预措施
Experimental
Prepared intravenous piggyback solution of caffeine citrate (200 mg caffeine) will be directly delivered to the operating room prior to the surgery of enrolled participants who are randomized to this group.
干预措施: Caffeine Citrate (Drug)
Control
Prepared intravenous piggyback solution of 5 percent dextrose water will be directly delivered to the operating room prior to the surgery of enrolled participants who are randomized to this group.
干预措施: Dextrose Water (Drug)
结局指标
主要结局
Cumulative Opioid Consumption: Postoperative Opioid Consumption, Oral Morphine Equivalents (mg)
时间窗: through postoperative day 3
Postoperative opioid consumption, oral morphine equivalents (mg)
次要结局
- Acute Pain (Patient-reported) as Assessed by Visual Analogue Scale(Data gathered from postoperative day 0-3. Final results were based on all values combined over this time period, per protocol.)
- Acute Pain (Observer-reported) as Assessed by Behavioral Pain Scale(Data gathered from postoperative day 0-3. Final results were based on all values combined over this time period, per protocol.)
- Number of Participants With Anxiety as Assessed by the Hospitalized Anxiety and Depression Scale (HADS-A)(baseline through postoperative day 3)
- Time Until Anesthetic Emergence(Duration of time from surgical dressing completion to anesthetic emergence (min); generally expected to be between 10 and 60 minutes)
- Cognitive Function as Assessed by Trail Making Test(morning of surgery baseline compared to postanesthesia care unit. Postanesthesia care unit measurement approximately 60 minutes after end of surgery)
- Positive Affect as Assessed by PANAS (Positive and Negative Affect Schedule)(postoperative day 3)
- Negative Affect as Assessed by PANAS (Positive and Negative Affect Schedule)(postoperative day 3)
- Percentage of Delirious Patients Per Group(By afternoon of postoperative day (POD) 3)
- Number of Participants With Depression as Assessed by the Hospitalized Anxiety and Depression Scale (HADS-D)(baseline through postoperative day 3)
研究者
Phillip Vlisides
Assistant Professor of Anesthesiology
University of Michigan