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临床试验/NCT06833671
NCT06833671已完成不适用

Effect of Preoperative Two Hours Carbohydrate Load On Pediatric Patient Undergoing Elective Surgery: A Randomized Controlled Study

Tanta University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年6月1日最近更新:
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
90
试验地点
1
主要终点
C-reactive protein (CRP) level

研究概览

简要总结

This work evaluated the systemic effect of different preoperative carbohydrate (CHO) loads in pediatrics undergoing elective surgery.

详细描述

Children undergoing surgery experience stress due to disruptions in their daily routine and exposure to various perioperative circumstances that induce anxiety and pain.

The management of perioperative nutrition in pediatric patients is a crucial aspect of patient care.

The concept of preoperative carbohydrate (CHO) loading has gained attention as a potential strategy to mitigate these drawbacks. The administration of a CHO-rich drink two hours preoperative has been proposed to maintain euglycemia, decline IR, and enhance postoperative recovery

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
Single (Outcomes Assessor)

入排标准

年龄范围
5 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age from 5 to 10 years.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) physical status I and II.
  • Scheduled for elective surgery.

排除标准

  • Diabetes mellitus.
  • Insulin resistance (IR).
  • Renal or hepatic insufficiency.
  • Esophageal or gastric surgery or gastrointestinal disorders history (including gastroesophageal reflux, hiatal hernia, or gastritis).

研究组 & 干预措施

Apple juice group

Experimental

A preoperative carbohydrate load was done two hours before the operation using a10 ml/kg, with a maximal volume of 250 ml of commercial brand of apple juice (glucose 28 g in 250 ml).

干预措施: Apple juice (Other)

Anhydrous glucose group

Experimental

A preoperative carbohydrate load was done using 1.75mg/kg/dose of anhydrous glucose (Alpha Chmika).

干预措施: Anhydrous glucose (Drug)

Water group

Other

Patients received water

干预措施: Water (Other)

结局指标

主要结局

C-reactive protein (CRP) level

时间窗: 4 hours postoperatively

C-reactive protein (CRP) level was assessed two h before surgery as baseline, at induction of anesthesia, and 4 hours after the operation.

次要结局

  • Neutrophil/ lymphocyte ratio(4 hours postoperatively)
  • Level of procalcitonin(4 hours postoperatively)
  • Homeostatic model assessment for insulin resistance(4 hours postoperatively)
  • Level of C-peptide(4 hours postoperatively)
  • Level of random blood glucose(Two hours before the surgery)
  • Patient's parent's satisfaction(4 hours postoperatively)
  • Incidence of complications(4 hours postoperatively)

研究者

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

Amany Mohamed Abotaleb

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Tanta University

研究点 (1)

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