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临床试验/NCT06376929
NCT06376929尚未招募不适用

Effect of Preoperative Low Dose Oral Carbohydrates Fluid Intake on Intraoperative Random Blood Glucose and Postoperative Nausea and Vomiting in Pediatric Patients Undergoing Ophthalmic Surgeries

Cairo University0 个研究点目标入组 120 人开始时间: 2024年5月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
主要终点
Mean values of Intraoperative random blood sugar in mg/dl

研究概览

简要总结

The correlation between preoperative oral carbohydrate intake and intraoperative random blood sugar and also the effect on postoperative nausea and vomiting.

详细描述

Surgeries are considered one of the most common causes of stress response in our bodies. Common stressors include prolonged fasting, anxiety, massive tissue injury, and release of inflammatory mediators.

Hospital stay and wound healing are considered common areas of postoperative distress.

Paediatric patients undergoing surgery are subjected to stress as they are removed from their ordinary daily routine and are exposed to a number of preoperative procedures that cause anxiety and discomfort.

One major cause of discomfort and stress is the need for preoperative fasting, which is needed and accepted all over the world as a standard precaution to minimise the risk of aspiration and regurgitation during induction of general anaesthesia. Based mainly on recommendations issued by anaesthesia societies worldwide, the standard guidelines for preoperative fasting in paediatric surgery is 6 hours for solid food , 6 hours for formula milk or cow milk, 4 hours for breast milk, and 2 h for clear fluids including clear juice and water.

This strategy of preoperative fasting is a significant contributor to postoperative nausea and vomiting, other reactions such as postoperative pain , inflammatory response to surgery, and perioperative insulin resistance which is thought to affect the random blood sugar RBS. Moreover, surgical stress response causes elevation of anti insulin hormones and reduces insulin secretion which can be detrimental for surgical patients in many aspects including recovery, wound healing, and duration of hospital stay. Criticisms of standard preoperative fasting have forced practitioners to explore new ways of preparing patients for theatre. Studies previously conducted in adults exposed to cholecystectomy showed that administration of a carbohydrate beverage diminishes insulin resistance and the organs' response to trauma.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Screening
盲法
None

入排标准

年龄范围
3 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Males and females
  • 3 years to 9 years
  • Undergoing ophthalmic surgeries
  • ASA I -II

排除标准

  • • Parent refusal
  • Age <3 or >9
  • Underlying proemetic disease
  • Positive history of Postoperative nausea and vomiting in patient, parent or sibling
  • Currently on antiemetic medications
  • History of juvenile diabetes
  • Lengthy operations more than 3 hours
  • intraoperative Blood transfusion

结局指标

主要结局

Mean values of Intraoperative random blood sugar in mg/dl

时间窗: 3 months

Mean values of Intraoperative random blood sugar in mg/dl

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

Sherif Mohamed Abd El Moneim Soaida, MD

assistant professor

Cairo University

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