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临床试验/NCT06243367
NCT06243367招募中不适用

Randomized Controlled Study of Preoperative Oral Carbohydrate Loading Versus Fasting in Patients Undergoing Major Abdominal Surgery

Tanta University2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
54
试验地点
2
主要终点
The metabolic response

研究概览

简要总结

The aim of this study is to compare the effect of preoperative carbohydrate load versus the fasting protocol in patients undergoing major abdominal operations.

详细描述

The surgical patients are influenced by many stressors during operation such as the prolonged fasting hours. Importantly, these stressors are iatrogenic and have been shown to disturb homeostasis with little benefit. Surgery itself, induces an endocrine and inflammatory stress response and contributes to postoperative insulin resistance (PIR) which increased also by Preoperative fasting.

Postoperative insulin resistance is a state of reduced insulin-mediated glucose uptake in skeletal muscles and adipose tissue, with an increased glucose release due to hepatic gluconeogenesis and hyperglycemia.

Strategies to reduce the postoperative stress response and postoperative insulin resistance include shortening the preoperative fasting time via preoperative carbohydrate oral drink administration (carbohydrate load). Preoperative fasting is the first step in postoperative insulin resistance development. The traditional fasting time of 6-8 h before elective surgery to prevent pulmonary aspiration usually extends up to 12 h in anesthetic practice. Overnight fasting is a physiological state of reduced insulin sensitivity due to the normal hormonal diurnal rhythm. If patients undergo surgery in the prolonged fasted state, insulin resistance may begin even before surgery.

A preoperative carbohydrate drink acts as a morning meal, may improve insulin sensitivity and propel the patient's metabolic state towards anabolism. The rationale of this study is to compare the differences between preoperative CHO loading and a conventional fasting protocol on the postoperative insulin resistance, Glasgow prognostic score (GPS), subjective patient well-being and surgical clinical outcome.

研究设计

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

入排标准

年龄范围
21 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age from 21 and 70 years.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) physical status l & ll.
  • Scheduled for elective major abdominal surgery

排除标准

  • Disseminated malignant disease.
  • Increased risk for gastric content aspiration.
  • Body Mass Index (BMI) below 20 or above 30 kg/m
  • Nutritional risk screening 2002 score above
  • Emergency surgery, diabetic patients, immunomodulatory therapy.
  • Refusal of the patient.

结局指标

主要结局

The metabolic response

时间窗: 5 days postoperatively

The patient was also subjected to further assessment by bioelectrical impedence analysis for measuring of the basal body muscle mass preoperatively and 5 days postoperatively.

次要结局

  • Time of independent ambulation(27 days postoperatively)
  • The postoperative inflammatory response(First day postoperative)
  • Postoperative discharge day(27 days postoperatively)
  • Complications(24 hours postoperatively)

研究者

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

Eman Mohammed Taher Salem Abo-Omar

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

Tanta University

研究点 (2)

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