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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Clinical Trial Center
- 電話番号：0131206893
- メール：clinicaltrialcenter@ospedale.al.it
研究場所
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Piedmont
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Alessandria、Piedmont、イタリア、15121
- 募集
- Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo
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コンタクト：
- Pediatric Surgery Unit Clinical Trial Center
- 電話番号：0131206893
- メール：clinicaltrialcenter@ospedale.al.it
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参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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Administration of 125 mL of a clear liquid containing maltodextrins two hours before elective pediatric surgery as part of the ERAS preoperative fasting protocol.
他の名前：
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プラセボコンパレーター：Control Group
Pediatric patients receiving 125 mL of a non-sugared clear liquid (water, tea, or chamomile) two hours before elective surgery.
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Administration of 125 mL of a non-sugared clear liquid (water, tea, or chamomile) two hours before elective pediatric surgery.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Preoperative anxiety measured by Modified Yale Preoperative Anxiety Scale (m-YPAS)
時間枠：20 to 30 minutes before surgery
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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.
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20 to 30 minutes before surgery
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Postoperative pain assessed by Visual Analogue Scale (VAS)
時間枠：2 hours after surgery
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Evaluation of postoperative pain using the Visual Analogue Scale (VAS) in pediatric patients after elective surgery.
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2 hours after surgery
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Eligibility for discharge after surgery
時間枠：6 hours after surgery
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Evaluation of the proportion of pediatric patients considered eligible for discharge 6 hours after elective surgery according to postoperative recovery and clinical conditions.
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6 hours after surgery
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Evaluation of postoperative vomiting
時間枠：Within 6 hours after surgery
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Incidence of participants experiencing at least one episode of postoperative vomiting during the first 6 hours after surgery.
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Within 6 hours after surgery
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Preoperative oxidative stress
時間枠：Immediately before surgery
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Blood chemistry tests for the assessment of preoperative stress
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Immediately before surgery
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Preoperative stress assessed by State-Trait Anxiety Inventory - Form Y (STAI-Y)
時間枠：Immediate preoperative period
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Evaluation of preoperative stress using the State-Trait Anxiety Inventory - Form Y) in parents of pediatric patients before elective surgery
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Immediate preoperative period
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Evaluation of postoperative oral feeding tolerance
時間枠：Within 6 hours after surgery
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Oral feeding tolerance will be assessed by the ability to tolerate the first oral intake without vomiting or need to interrupt feeding.
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Within 6 hours after surgery
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ASO.ChirPed.24.05
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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