The Effect of Ketamine on Production of Inflammatory Markers in Post Operative Patients in Mulago Hospital: A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- changes/deviations from baseline levels of IL-6 pro-inflammatory markers of after surgery
研究概览
简要总结
. 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Ketamine
will be given low sub-anesthetic doses of Ketamine 0.5mg/kg.
干预措施: Ketamine (Drug)
Placebo
will get placebo treatment
干预措施: Ketamine (Drug)
结局指标
主要结局
changes/deviations from baseline levels of IL-6 pro-inflammatory markers of after surgery
时间窗: 48 hours
changes/deviations from baseline levels of IL-6 pro-inflammatory markers of after surgery at Post Anesthesia Care Unit, 24 and 48 hours
次要结局
- changes/deviations from baseline levels of IL-1β pro-inflammatory markers of after surgery(48 hours)