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临床试验/CTRI/2024/10/075002
CTRI/2024/10/075002尚未招募不适用

Impact of Actual Preoperative Fasting Duration on Blood Glucose, Hemodynamics, Child Thirst and Hunger Score in Pediatric Elective Surgery patients: A Prospective Observational Study

Medipulse hospital1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2024年10月20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
128
试验地点
1
主要终点
To evaluate and record actual preoperative fasting hours for clear liquid for the selected children included in the study sample.

研究概览

简要总结

The current guidelines for preoperative fasting recommend intervals of 6, 4, and 2 h (6-4-2) of fasting for solids, breast milk, and clear fluids, respectively. The objective is to minimize the risk of pulmonary aspiration of gastric contents, but also to prevent unnecessarily long fasting intervals.However, despite these clear recommendations, fasting times are often prolonged both in India and globally.]Various factors contribute to non-compliance with guidelines, including organizational issues, communication problems, inadequate understanding of fasting instructions or necessity, intentional misinformation to avoid procedure cancellation, and conflicting instructions from multiple sources. Fasting leads to thirst, hunger and anxiety. Young children are used to eat more often than adults and it is also hard to explain to a small child why they cannot eat. Preoperative fasting may thus lead to additional anxiety and discomfort, in children already anxious because of the hospital environment and preoperative procedures. Not surprisingly, several studies show that children allowed to drink prior to surgery show less thirst, hunger and discomfort, than children that are kept fasting for longer periods.

Considering these studies and results, we planned to conduct a prospective observational study in pediatric population to evaluate actual preoperative fasting and its intraoperative pathophysiological effect.

In this study our aim is to evaluate the actual duration of preoperative fasting and its effect on blood glucose levels and hemodynamics in pediatric population age group 5 to 12 years undergoing elective surgical procedure under general anaesthesia.

研究设计

研究类型
Observational

入排标准

年龄范围
5.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • All patients with American Society of Anaesthesiology-Physical Status Grade I or II of either sex, aged between 5 years and 12 years, and undergoing elective surgeries under general anaesthesia, will be included in the study.

排除标准

  • Refusal of parental consent Patients undergoing emergency surgery Patients with increased risk of aspiration eg.
  • patients with full stomach, patients with trache-esophageal fistula, patients with impaired consciousness, patients with swallowing disorders.
  • History of prematurity, seizures, syndromic babies and congenital heart disease History of recent upper respiratory tract infection Patients ASA grade more the 2.

结局指标

主要结局

To evaluate and record actual preoperative fasting hours for clear liquid for the selected children included in the study sample.

时间窗: Just prior to surgery in preoperative ward

次要结局

  • To evaluate and record actual preoperative fasting hours for solids and to evaluate children hunger and thirst score and effects on hemodynamics intraoperatively.(Just after induction and then after frequent time interval intraoperatively.)

研究者

发起方
Medipulse hospital
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Kamal chitara

Medipulse Hospital Jodhpur Rajasthan

研究点 (1)

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