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临床试验/NCT05663164
NCT05663164已完成不适用

Effect of Thiamine on Serum Glucagon And Reactive Oxygen Species (ROS) in Perioperative Stress Response

Universitas Sumatera Utara1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年10月1日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Vitamin B1 (thiamine) 100mg every 6 hours x 3-days

干预措施: Vitamin B (Drug)

Drug: Normal saline

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bastian Lubis

Head of Intensive Care Unit

Universitas Sumatera Utara

研究点 (1)

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