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Use of Maltodextrins in the ERAS Preoperative Fasting Protocol in Pediatric Surgery (ERAS-MALTO)

Use of Maltodextrins in the ERAS Preoperative Fasting Protocol in Pediatric Surgery: A Pilot Randomized Controlled Study

This monocentric prospective randomized controlled pilot study aims to evaluate the effectiveness of preoperative maltodextrin administration within an Enhanced Recovery After Surgery (ERAS) protocol in pediatric surgical patients. Children aged 3 to 8 years undergoing elective day surgery will be randomized 1:1 to receive either a maltodextrin-containing clear liquid or a non-sugared clear liquid before surgery. The study will assess preoperative anxiety, patient compliance, parental anxiety, oxidative stress markers, postoperative feeding tolerance, and postoperative recovery outcomes.

研究概览

详细说明

Enhanced Recovery After Surgery (ERAS) protocols are multidisciplinary perioperative care programs developed to reduce surgical stress, improve postoperative recovery, and shorten hospital stay. In adult surgical populations, preoperative administration of carbohydrate-rich clear fluids has been associated with reduced insulin resistance, improved metabolic response, reduced postoperative nausea, and improved patient comfort.

Evidence regarding the use of these strategies in pediatric surgical patients remains limited. This prospective randomized controlled no-profit pilot study aims to evaluate the clinical impact of preoperative maltodextrin administration in children undergoing elective surgery.

Approximately 200 pediatric patients aged 3 to 8 years undergoing elective day surgery at the Pediatric Surgery Unit of the Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo of Alessandria will be enrolled. Participants will be randomized 1:1 to receive either a maltodextrin-containing clear liquid or a non-sugared clear liquid two hours before surgery.

Primary outcome evaluation includes preoperative anxiety assessed using the Modified Yale Preoperative Anxiety Scale (m-YPAS). Secondary outcomes include parental anxiety, oxidative stress markers, postoperative feeding tolerance, postoperative vomiting, postoperative pain evaluation, and discharge eligibility after surgery.

Clinical, demographic, laboratory, anesthesiologic, and perioperative data will be collected and analyzed to assess the feasibility and effectiveness of this ERAS-based intervention in pediatric surgical patients.

研究类型

介入性

注册 (估计的)

200

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Piedmont
      • Alessandria、Piedmont、意大利、15121
        • 招聘中
        • Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

是的

描述

Inclusion Criteria:

  • Pediatric patients aged 3 to 17 years
  • Patients undergoing elective surgery in a day surgery setting
  • Surgical procedure duration less than 60 minutes
  • Written informed consent signed by a parent or legal guardian

Exclusion Criteria:

  • Maltodextrin intake within 3 hours before surgery
  • Allergy or intolerance to maltodextrins
  • Diabetes mellitus or other metabolic disorders potentially affecting study variables
  • Inadequate nutritional status based on body mass index (BMI)
  • Absence of signed informed consent by parent or legal guardian

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Maltodextrin Group
Pediatric patients receiving 125 mL of a clear liquid containing maltodextrins two hours before elective surgery as part of the ERAS preoperative fasting protocol.
Administration of 125 mL of a clear liquid containing maltodextrins two hours before elective pediatric surgery as part of the ERAS preoperative fasting protocol.
其他名称:
  • Carbohydrate Loading
  • Maltodextrins
安慰剂比较:Control Group
Pediatric patients receiving 125 mL of a non-sugared clear liquid (water, tea, or chamomile) two hours before elective surgery.
Administration of 125 mL of a non-sugared clear liquid (water, tea, or chamomile) two hours before elective pediatric surgery.
其他名称:
  • Placebo Beverage
  • Clear Liquid

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Preoperative anxiety measured by Modified Yale Preoperative Anxiety Scale (m-YPAS)
大体时间:20 to 30 minutes before surgery
Evaluation of preoperative anxiety and agitation in pediatric surgical patients receiving maltodextrin-containing clear liquids compared with control patients receiving non-sugared clear liquids before elective surgery.
20 to 30 minutes before surgery

次要结果测量

结果测量
措施说明
大体时间
Postoperative pain assessed by Visual Analogue Scale (VAS)
大体时间:2 hours after surgery
Evaluation of postoperative pain using the Visual Analogue Scale (VAS) in pediatric patients after elective surgery.
2 hours after surgery
Eligibility for discharge after surgery
大体时间:6 hours after surgery
Evaluation of the proportion of pediatric patients considered eligible for discharge 6 hours after elective surgery according to postoperative recovery and clinical conditions.
6 hours after surgery
Evaluation of postoperative vomiting
大体时间:Within 6 hours after surgery
Incidence of participants experiencing at least one episode of postoperative vomiting during the first 6 hours after surgery.
Within 6 hours after surgery
Preoperative oxidative stress
大体时间:Immediately before surgery
Blood chemistry tests for the assessment of preoperative stress
Immediately before surgery
Preoperative stress assessed by State-Trait Anxiety Inventory - Form Y (STAI-Y)
大体时间:Immediate preoperative period
Evaluation of preoperative stress using the State-Trait Anxiety Inventory - Form Y) in parents of pediatric patients before elective surgery
Immediate preoperative period
Evaluation of postoperative oral feeding tolerance
大体时间:Within 6 hours after surgery
Oral feeding tolerance will be assessed by the ability to tolerate the first oral intake without vomiting or need to interrupt feeding.
Within 6 hours after surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年9月3日

初级完成 (估计的)

2027年5月1日

研究完成 (估计的)

2027年6月1日

研究注册日期

首次提交

2026年6月22日

首先提交符合 QC 标准的

2026年7月2日

首次发布 (实际的)

2026年7月6日

研究记录更新

最后更新发布 (实际的)

2026年7月6日

上次提交的符合 QC 标准的更新

2026年7月2日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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