The Effect of Ketamine on Production of Inflammatory Markers in Post Operative Patients in Mulago Hospital
The Effect of Ketamine on Production of Inflammatory Markers in Post Operative Patients in Mulago Hospital: A Randomized Clinical Trial
. Null Hypothesis: Giving low doze ketamine (0.5mg/kg) given preoperatively to adult patients undergoing elective surgery, in Mulago hospital, will not have a reduction effect on the levels of IL-6 & IL-1β pro inflammatory markers by 48 hours.
. Alternate Hypothesis: Giving low doze ketamine (0.5mg/kg) given preoperatively to adult patients undergoing elective surgery, in Mulago hospital, will have a reduction effect on the levels of IL-6 & IL-1β pro inflammatory markers by 48 hours.
研究概览
详细说明
RESEARCH QUESTION Can 0.5mg/kg of Ketamine given preoperatively have an effect on the levels of pro-inflammatory markers?
Primary specific Outcome: changes/deviations from baseline levels of IL- 6 pro-inflammatory markers of after surgery at PACU, 24 and 48 hours.
Secondary specific Outcome: changes/deviations from baseline levels of IL-1β pro-inflammatory markers of after surgery at PACU, 24 and 48 hours.
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习地点
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Kampala、乌干达、+256
- 招聘中
- Mulago Hospital National Refferal, surgical wards
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接触：
- John M Kasumba, MBChB, MMed Anaesthesia- MUK
- 电话号码：+256701625678 +25675625678
- 邮箱：drkasmaya@gmail.com
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首席研究员：
- Tonny S Luggya, MBChB- MUK
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参与标准
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:
- Consented patients due for elective surgery
- Adult patients 18- 70 year old
- ASA I- ASA II scoring patients, who are normal patients or those with mild systemic illness
Exclusion Criteria:
- Emergency cases that will already have high levels of inflammatory markers secreted in their system by incision time e.g. road traffic accidents
- Patients with chronic / severe hypertension
- Febrile Patients (T >38°C)
- Persistently raised blood pressures above 140/90 for 2 consistent readings 15 minutes apart
- Patients with pheochromocytoma
- Spinal and local infiltration anaesthesia cases
- Neuro surgery patients whom Ketamine is contra indicated
- Epilepsy patients
- ASA IIIE and above
- Patients receiving Aspirin prophylaxis
- Chronic inflammatory disease states such as hyperparathyroidism
学习计划
研究是如何设计的？
设计细节
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Ketamine
will be given low sub-anesthetic doses of Ketamine 0.5mg/kg.
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determining the effect of low dose sub anesthetic doze of ketamine and placaebo on post operative patients
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安慰剂比较：Placebo
will get placebo treatment
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determining the effect of low dose sub anesthetic doze of ketamine and placaebo on post operative patients
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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changes/deviations from baseline levels of IL-6 pro-inflammatory markers of after surgery
大体时间：48 hours
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changes/deviations from baseline levels of IL-6 pro-inflammatory markers of after surgery at Post Anesthesia Care Unit, 24 and 48 hours
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48 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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changes/deviations from baseline levels of IL-1β pro-inflammatory markers of after surgery
大体时间：48 hours
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changes/deviations from baseline levels of IL-1β pro-inflammatory markers of after surgery at PACU, 24 and 48 hours
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48 hours
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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