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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Clinical Trial Center
- Numéro de téléphone: 0131206893
- E-mail: clinicaltrialcenter@ospedale.al.it
Lieux d'étude
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Piedmont
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Alessandria, Piedmont, Italie, 15121
- Recrutement
- Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo
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Contact:
- Pediatric Surgery Unit Clinical Trial Center
- Numéro de téléphone: 0131206893
- E-mail: clinicaltrialcenter@ospedale.al.it
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
Autres noms:
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Comparateur placebo: 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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Preoperative anxiety measured by Modified Yale Preoperative Anxiety Scale (m-YPAS)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Postoperative pain assessed by Visual Analogue Scale (VAS)
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Les troubles mentaux
- Maladies métaboliques
- Troubles du métabolisme du glucose
- Hyperinsulinisme
- Comportement
- Maladies nutritionnelles et métaboliques
- Comportement alimentaire
- Troubles anxieux
- Résistance à l'insuline
- Jeûne
- Thérapeutique
- Régime, nourriture et nutrition
- Phénomènes physiologiques
- Phénomènes physiologiques nutritionnels
- Thérapie de régime
- Thérapie nutritionnelle
- Régime
- Régime, Charge en Glucides
Autres numéros d'identification d'étude
- ASO.ChirPed.24.05
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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