Effect of Thiamine on Serum Glucagon And Reactive Oxygen Species (ROS)

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Sepsis, Thiamine Deficiency

Intervention / Treatment
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* Drug: Vitamin B
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18-65 years who undergo surgery under general anesthesia ASA physical statuses 1 and 2 Sepsis Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Vitamin B1<br>Vitamin B1 (thiamine) 100mg every 6 hours x 3-days | Drug: Vitamin B<br>* vitamin B1 (100mg) will be diluted in 50 ml 0.9% NACL(normal saline) and administered IV every 6 hours for 3 days<br>* Other names: Thiamine;|
| Placebo Comparator: Drug: Normal saline<br>Normal saline (0.9% NaCl solution) volume to match all components | Drug: Placebo<br>* Normal saline (0.9% NaCl solution) volume to match all components<br>* Other names: Normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucagon Level | a hormone that your pancreas makes to help regulate your blood glucose (sugar) levels | On day 3 (at approximately 72 hours) after the first study drug dose | 
| ROS Level | 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 | On day 3 (at approximately 72 hours) after the first study drug dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thiamine, sepsis, glucagon, ROS, Perioperative Stress Response