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临床试验/NCT06242275
NCT06242275已完成不适用

Perioperative Salivary Alpha-amylase as a Predictor of Delirium After Lower Extremity Vascular Bypass Surgery

Tanta University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年2月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
The accuracy of salivary alpha-amylase as a predictor of postoperative delirium

研究概览

简要总结

The aim of this study is to evaluate the role of salivary Alpha-amylase as a predictor biomarker of POD in elderly patients undergoing limb bypass surgery.

详细描述

Delirium is a neuropsychiatric syndrome that is characterized by the sudden onset of altered awareness, decreased ability to maintain attention, and disorders of the mental process. The pathophysiology of Postoperative delirium (POD) is related to postoperative neuroinflammation.

Biomarkers not only indicate a certain pathological state, but also provide information about disease activity and progression. Although several biomarkers are reported to predict POD, biomarkers with high sensitivity and specificity are still lacking.

Biochemical parameters associated with complement cascade (C3a, C3, C5a) and inflammatory response (IL-17A, IL-33, E-selectin, MMP9) were involved in neurocognitive regulation.

Salivary alpha amylase (SAA) enzyme is one of the most important enzyme compositions in the saliva that accounts for 40% to 50% of the total salivary proteins, and most of it is secreted from the parotid gland. SAA is locally produced by the highly differentiated epithelial acinar cells of the exocrine salivary glands, mostly of the parotid glands and plays an important role in carbohydrate hydrolysis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 65 years.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) physical status III.
  • Undergoing lower extremity vascular surgery under general anesthesia.

排除标准

  • Patients who used any medication that could affect salivary glands (such as antihypertensive, antidepressants or antipsychotic drugs).
  • Inability to communicate.
  • History of psychiatric diseases or previous stroke
  • Previous history of pod.
  • Those with smoking and drinking habits.
  • Pregnant female.

结局指标

主要结局

The accuracy of salivary alpha-amylase as a predictor of postoperative delirium

时间窗: 3rd day postoperatively

The accuracy of salivary alpha-amylase will be measured by saliva samples which will be obtained using a saliva collection system and SAA level will be measured preoperatively, immediately postoperative, at the end of the 1st, 2nd, and 3rd postoperative days.

次要结局

  • Incidence of postoperative delirium(first 5 days after surgery)
  • Correlation of salivary alpha-amylase with C-reactive protein(24 hours postoperatively)
  • Correlation of salivary alpha-amylase with average pain score(24 hours postoperatively)
  • Correlation of salivary alpha-amylase with morphine consumption(24 hours postoperatively)

研究者

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

ِAhmed Mohamed Ibrahim

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Tanta University

研究点 (1)

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