The Effect and Contribution of a Perioperative Ketamine Infusion in an Established Enhanced Recovery Pathway
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,570
- 试验地点
- 1
- 主要终点
- Length of Stay
研究概览
简要总结
In order to effectively treat surgical pain with the least amount of opioids required, a multi-modal approach must include medications with different mechanisms of actions at alternative receptors. In light of the opioid epidemic, medical providers at Vanderbilt University Medical Center (VUMC) are strategically combining these medications in a bundled pain-regimen after surgery. These regimens have been shown to decrease opioid consumption, improve surgical outcomes, and reduce hospital stays, thus coining the term 'enhanced recovery pathway'. The combination of these medications has an indisputable synergistic effect. However, it is unknown how each medication contributes individually to the overall efficacy of the pathway. This study will examine the effects of ketamine, within the constructs of a multimodal pain regimen, on a) length of stay, b) opioid consumption, and c) surgical outcomes after major abdominal surgery.
详细描述
Opioids are powerful analgesic medications that can reduce pain through action at the mu receptor. Unfortunately, activation of the mu receptor also results in undesirable side effects, such as respiratory depression, sedation, bowel ileus, nausea, itching, and tolerance. Therefore, in order to effectively treat pain with the least amount of opioids required, a multi-modal approach must include medications with different mechanisms of actions at alternative receptors. Some examples of non-narcotic pain medications include acetaminophen (Tylenol), anti-inflammatories (NSAIDS), muscle relaxants, local anesthetics, gabapentinoids (Lyrica), and ketamine, to name a few. In light of the opioid epidemic, medical providers at Vanderbilt University Medical Center (VUMC) are strategically combining these medications in a bundled pain-regimen after surgery. These regimens have been shown to decrease opioid consumption, improve surgical outcomes, and reduce hospital stays, thus coining the term 'enhanced recovery pathway' or enhanced recovery after surgery (ERAS). The combination of these medications has an indisputable synergistic effect. However, it is unknown how each medication contributes individually to the overall efficacy of the pathway. Ultimately, the investigators aim to perform a series of randomized controlled trials in which we isolate each component of the pathway to investigate its effects on length of stay, total opioid consumption, and surgical outcomes. The investigators will begin with studying ketamine.
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)
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
- •18 years old or greater
- •presenting at VUMC for abdominal surgery on the colorectal, ventral hernia or surgical oncology services on a weekday.
排除标准
- •allergy or contraindication to ketamine
- •unable or refuse to receive a neuraxial or regional nerve block
- •patient refusal
- •direct transfer from operating room to intensive care unit with endotracheal tube placed
- •treating team elects to exclude the patient prior to study drug administration
- •abortion of planned surgical procedure
研究组 & 干预措施
Ketamine
Participants in this arm will receive intraoperative ketamine bolus (0.5mg/kg) followed by continuous infusion 5 mcg/kg/min and also will receive postoperative ketamine infusion (2.5 mcg/kg/min, up to 100kg max) for 48 hours.
干预措施: Ketamine (Drug)
Saline
Participants in this arm will receive an equivalent volume of intraoperative saline bolus followed by continuous saline infusion and also will receive postoperative saline infusion for 48 hours.
干预措施: Placebo (Drug)
结局指标
主要结局
Length of Stay
时间窗: From surgery start until discharge, typically 3-5 days
The participants length of stay, from anesthesia beginning to discharge, measured in days
次要结局
- Total Consumption of Inpatient Opioids(From hospital admission until discharge, typically 3-5 days)
- Number of Participants With Ileus(From hospital admission until discharge, typically 3-5 days)
- Number of Participants Who Encounter Rapid Response Team Activation(From hospital admission until discharge, typically 3-5 days)
- Number of Participants Who Experienced ICU Transfer(From hospital admission until discharge, typically 3-5 days)
- Number of Participants Who Experienced Adverse Side Effects(From hospital admission until discharge, typically 3-5 days)
研究者
Britany Lynn Raymond, MD
MD, Assistant Professor, Department of Anesthesiology
Vanderbilt University Medical Center