接受 NCI 接受 TEVAR 手术的患者使用氯胺酮 (2020Ketamine)
一项随机、双盲、安慰剂对照的研究,旨在确定低剂量氯胺酮对接受 NCI 接受 TEVAR 手术的患者的阿片类药物节约效应和镇痛潜力
The objective of this study is to identify the opioid-sparing effects, and pain-reduction potential of low dose, sub-dissociative ketamine on patients undergoing thoracic endovascular aortic repair (TEVAR) procedures receiving naloxone continuous infusion (NCI).
研究概览
地位
地位
条件
条件
干预/治疗
干预/治疗
详细说明
Patients undergoing descending aortic repair often experience post-operative pain, and have high post operative opioid requirements. That pain is partially due to the use of naloxone continuous infusion (NCI). NCI is part of a bundled approach used in the first 48 hours post-operatively to prevent spinal cord ischemia, a devastating complication associated with surgical repair of the descending aortic. Data indicate that patients receiving NCI experience elevated post-operative pain scores and increased opioid requirements during the 48-hr post-operative NCI administration, compared to patients not receiving NCI.
Ketamine is an FDA-approved N-methyl D-aspartate (NMDA) antagonist that has been shown to provide adjunctive analgesia and opioid-sparing effects in post-operative surgical patients. At low doses, ketamine provides analgesic benefit without the anesthetic effects seen at higher doses. These doses are commonly referred to sub-dissociative. This study will evaluate whether use of sub dissociative ketamine (SDK) in patients undergoing aortic procedures with the use of NCI will lead to decreased post-operative opioid consumption, and produce improved pain scores in the first 48 hours.
研究类型
研究类型
注册 (实际的)
注册
阶段
阶段
- 阶段2
联系人和位置
学习地点
-
-
Kentucky
-
Lexington、Kentucky、美国、40536
- University of Kentucky Medical Center
-
-
参与标准
资格标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- willing to give informed consent
- scheduled for elective thoracic aorta repair or thoracoabdominal aortic repair
- requires naloxone continuous infusion for spinal prophylaxis
Exclusion Criteria:
- allergy to ketamine, acetaminophen, or fentanyl
- diagnosis of schizophrenia
- history of hydrocephalus or central nervous system mass
- incarcerated individuals
- pregnant or lactating individuals
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
手臂数量
武器和干预
参与者组/臂参与者组/臂 |
干预/治疗干预/治疗 |
|---|---|
|
安慰剂比较:Standard of Care
Participants in this group will receive standard of care as well as a saline infusion during the study period. |
Saline infusion |
|
实验性的:Sub-Dissociative Ketamine
Participants in this group will receive standard of care as well as a continuous ketamine infusion at the induction of anesthesia and for 48 hours postoperatively. |
Continuous ketamine infusion at a dose of 0.2 mg/kg/hr, initiated at the induction of anesthesia and continued for 48 hours postoperatively. |
研究衡量的是什么?
主要结果指标
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cumulative Opioid Dose
大体时间:48 hours
|
Total morphine milligram equivalents (MME) will be assessed every 6 hours for 48 hours. |
48 hours
|
次要结果测量
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Pain
大体时间:48 hours
|
Pain will be assessed using a 10-Point Numerical Pain Scale (as part of standard of care) every hour for the first 24 hours and every two hours for the next 24 hours. Scores range from 0-10; higher scores indicated higher levels of pain. |
48 hours
|
|
Number of Patients with Ketamine-Induced Delirium
大体时间:48 hours
|
Ketamine-induced delirium will be monitored via the Confusion Assessment Method (CAM-ICU) survey every 8 hours for 48 hours. The CAM-ICU assesses four diagnostic features of delirium and the result is a binary (yes or no) determination. |
48 hours
|
|
Number of Patients with Uncontrolled Hypertension
大体时间:48 hours
|
Uncontrolled hypertension is defined as a systolic pressure of 160 mmHg despite 3 intravenous antihypertensive agents. |
48 hours
|
合作者和调查者
调查人员
调查人员
- 研究主任:Anna Rockich, Pharm D、University of Kentucky
- 首席研究员:Samuel Tyagi, MD、University of Kentucky
研究记录日期
研究主要日期
学习开始 (实际的)
学习开始
初级完成 (实际的)
初级完成
研究完成 (实际的)
研究完成
研究注册日期
首次提交
首次提交
首先提交符合 QC 标准的
首先提交符合 QC 标准的
首次发布 (实际的)
首次发布
研究记录更新
最后更新发布 (实际的)
最后更新发布
上次提交的符合 QC 标准的更新
上次提交的符合 QC 标准的更新
最后验证
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
其他研究编号
- 60617
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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