Use of Maltodextrins in the ERAS Preoperative Fasting Protocol in Pediatric Surgery: A Pilot Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Preoperative anxiety measured by Modified Yale Preoperative Anxiety Scale (m-YPAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
None (Open Label)
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Preoperative anxiety measured by Modified Yale Preoperative Anxiety Scale (m-YPAS)
时间窗: 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.
次要结局
- Postoperative pain assessed by Visual Analogue Scale (VAS)(2 hours after surgery)
- Eligibility for discharge after surgery(6 hours after surgery)
- Evaluation of postoperative vomiting(Within 6 hours after surgery)
- Preoperative oxidative stress(Immediately before surgery)
- Preoperative stress assessed by State-Trait Anxiety Inventory - Form Y (STAI-Y)(Immediate preoperative period)
- Evaluation of postoperative oral feeding tolerance(Within 6 hours after surgery)