Effect of Thiamine on Serum Glucagon And Reactive Oxygen Species (ROS) in Perioperative Stress Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Glucagon Level
研究概览
简要总结
This research is a clinical trial with a Randomized Controlled Trial (RCT) design. The purpose is to identify the effect of intravenous thiamine administration compared to normal saline placebo on glucagon levels and ROS levels in patients undergoing general anesthesia surgery
详细描述
Surgery may increase postoperative cortisol and blood glucose levels. Changes in normal metabolic patterns due to surgery stimulate gluconeogenesis, glycogenolysis, proteolysis, lipolysis, and cytogenesis. These result in hyperglycemia and ketosis conditions. Surgery and anesthesia lead to an immunosuppressive effect. Increased secretion of proinflammatory cytokines may also occur after the surgery.
Besides an increase in cortisol levels, surgery can also increase cytokine response and ROS production in patients who have undergone surgery under general anesthesia after 72 hours. ROS production can also be a useful indicator in assessing the severity of surgical trauma.
In surgical procedures, there is an acute increase in reactive oxidative stress (ROS). This occurs when ischemia is followed by reperfusion. ROS can trigger tissue injury seen in transplantation (liver and heart), the release of aortic clamps during abdominal and thoracic aortic surgery, the release of limb tourniquets during orthopedic surgery, and reperfusion during and after cardiopulmonary bypass. There is a thiamine deficiency in 20% of patients treated in the intensive care unit (ICU). Thiamine deficiency is a source of lactic acidosis that does not seem in severe sepsis and septic shock. An imbalance between the formation and removal of free radicals causes a pathological condition called oxidative stress. However, the human body uses antioxidants to suppress these free radicals. One of the antioxidants that can reduce oxidative stress is thiamine. Previous studies proved this finding. Thiamine has also been able to significantly prevent the expression of inflammatory cytokines and chemokines, depending on NF-B induced by thromboxane and PGI2 synthase.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-65 years who undergo surgery under general anesthesia
- •ASA physical statuses 1 and 2
排除标准
- •Refuse to participate
- •Diabetes mellitus, experience shock sepsis or lactic acidosis
- •Have a history of hypersensitivity (allergy) to thiamine
- •Thiamine deficiency
- •Take immunomodulatory drugs, antiplatelet or anticoagulants surgery duration > 6 hours, and thiamin regularly
- •They experience massive bleeding and receive blood transfusions preoperatively, intraoperatively, or postoperatively
研究组 & 干预措施
Experimental: Vitamin B1
Vitamin B1 (thiamine) 100mg every 6 hours x 3-days
干预措施: Vitamin B (Drug)
Drug: Normal saline
Normal saline (0.9% NaCl solution) volume to match all components
干预措施: Placebo (Drug)
结局指标
主要结局
Glucagon Level
时间窗: On day 3 (at approximately 72 hours) after the first study drug dose
a hormone that your pancreas makes to help regulate your blood glucose (sugar) levels
ROS Level
时间窗: On day 3 (at approximately 72 hours) after the first study drug dose
Reactive species is the common term for both free radicals and reactive oxygen species (ROS), which include radicals, such as superoxide radical anion and hydroxyl radical, and nonradicals, such as hydrogen peroxide
次要结局
未报告次要终点
研究者
Bastian Lubis
Head of Intensive Care Unit
Universitas Sumatera Utara
