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临床试验/CTRI/2023/08/056106
CTRI/2023/08/056106尚未招募不适用

Effect of preoperative intravenous Ascorbic acid on serum levels of C - Reactive Protein as a marker of surgical stress response in laparoscopic gynaecological procedure under general anaesthesia.

Atal Bihari Vajpaee Institute Of Medical Sciences And Dr Ram Manohar Lohia Hospital1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2023年8月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
56
试验地点
1
主要终点
Serum Level Of C- Reactive Protein

研究概览

简要总结

Surgical stress is the systematic response to surgical injury and is characterized by activation of the sympathetic nervous system, endocrine responses as well as immunological and metabolic changes. In laparoscopic procedures intraperitoneal carbon dioxide insufflation and intraoperative organ handling also causes stress. As a result of these changes, plasma concentrations of neuroendocrine markers such as Cortisol, Glucagon, Insulin, Anti diuretic hormone and inflammatory immune markers such as C-Reactive Protein, Lactate, Catecholamines etc increases.

When this response is uncontrolled, it leads to postoperative complications like tachycardia, increased myocardial oxygen demand, tissue hypoxia, cellular acidosis, and poor long term outcomes like muscle wasting, impaired immune function and delayed wound healing, and if left unattended, organ failure and death.

Over the years many methods have been used to reduce the perioperative surgical stress response. These include using physiologic monitoring, providing balanced anaesthesia care and pain control, prescribing appropriate antibiotics, supporting patients by metabolic and nutritional means, and using new methods of imaging to aid in diagnosis.In pharmacological method of attenuating this surgical stress response variety of drugs have been studied, e.g.NSAIDS, Clonidine, Dexmedetomidine, opioids, Vitamin C etc. All of them show beneficial response to obtund the surgical stress response.

Out of these Vitamin C has shown a proven role in reducing the inflammatory response in sepsis. It stimulates the immune system in response to inflammation, by enhancing T-lymphocyte proliferation, which is postulated to be done by inhibition of signalling pathways involved in T cell apoptosis. This action leads to increased cytokine production and immunoglobulin synthesis. Ascorbic acid being structurally similar to glucose, helps in prevention of non-enzymatic glycosylation of proteins .Ascorbic acid’s anti-inflammatory properties are due to its hepatic messenger RNA expression of the tumour factors and interleukins downregulation.

Very few studies have studied the effect of intravenous vitamin C on acute stress response as the surgical stress response, showing benefits of pre-operative Vitamin C. But most of these studies are in western population.

 Hence, we have planned this study to evaluate the effect of preoperative intravenous ascorbic acid on surgical response in patients undergoing Diagnostic Hysterolaparoscopy surgery.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
Female

入选标准

  • Women aged 18 To 65 years posted for Elective Diagnostic Hysterolaparoscopic surgery.
  • ASA Class I AND II.

排除标准

  • Patients with endocrine morbidities such as Diabetes Mellitus, Hypopituitarism, Cushings disease Patients with Hypertension.
  • Heart diseases such as Coronary Heart disease, Valvular Heart disease.
  • Patients already on Steroid treatment.

结局指标

主要结局

Serum Level Of C- Reactive Protein

时间窗: T0 Baseline - Just After Cannulation | T1 - 5 Minutes After Creating Pneumoperitonium | T2 - Immediately After Extubation | T3 - 12 Hours After Extubation

次要结局

  • Levels Of(A. Blood Sugar)
  • Hemodynamic Stress Response.( Heart Rate, Systolic Blood Pressure , Diastolic Blood Pressure, Mean Arterial Pressure)(T0 Baseline - Just After Cannulation)

研究者

发起方
Atal Bihari Vajpaee Institute Of Medical Sciences And Dr Ram Manohar Lohia Hospital
申办方类型
Government medical college

研究点 (1)

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