Effect of Colchicine as premedication on perioperative inflammatory response in relation to IL6 and CRP levels in major elective oncological surgeries: a pilot study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- to compare the preoperative with postoperative values of IL6 and CRP levels to know the effectiveness of colchicine as anti-inflammatory agent in oncological surgery patients to be considered as part of ERAS model.
研究概览
简要总结
In the present pilot study, we wish to evaluate the efficacy of
administration of colchicine as premedication in suppressing the
postoperative inflammatory response in terms of IL6 and CRP levels on
the first postoperative day such that it can be incorporated in the protocol
for Early Recovery After Surgery to improve patient outcomes. Primary
pilot objective will be to compare the levels of inflammatory markers
namely IL6 and CRP preoperatively and postoperatively after
administering single dose of 1.2 mg oral colchicine on the morning of
planned surgery. This pilot study can also serve as the foundation for a
larger multicentre trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •major elective gastrointestinal or gynaecological tumour resection in ASA I and II patients of both sexes.
排除标准
- •age less than 18 years, patients unable to give consent, patients posted for any emergency surgery, patients with renal or hepatic impairment, patients with history of allergy to colchicine and patients with immunosuppressive illness other than neoplasm will be excluded from the study.
结局指标
主要结局
to compare the preoperative with postoperative values of IL6 and CRP levels to know the effectiveness of colchicine as anti-inflammatory agent in oncological surgery patients to be considered as part of ERAS model.
时间窗: preoperatively at 9 am on morning of surgery and at 9 am on morning of postoperative day 1
次要结局
未报告次要终点
研究者
Prerna Bhola
ESIC Medical College