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
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Clinical Trial Center
- Telefoonnummer: 0131206893
- E-mail: clinicaltrialcenter@ospedale.al.it
Studie Locaties
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Piedmont
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Alessandria, Piedmont, Italië, 15121
- Werving
- Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo
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Contact:
- Pediatric Surgery Unit Clinical Trial Center
- Telefoonnummer: 0131206893
- E-mail: clinicaltrialcenter@ospedale.al.it
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
Andere namen:
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Placebo-vergelijker: 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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Preoperative anxiety measured by Modified Yale Preoperative Anxiety Scale (m-YPAS)
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Postoperative pain assessed by Visual Analogue Scale (VAS)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Psychische aandoening
- Metabole ziekten
- Glucosemetabolismestoornissen
- Hyperinsulinisme
- Gedrag
- Voedings- en stofwisselingsziekten
- Voedingsgedrag
- Angst stoornissen
- Insuline-resistentie
- Vasten
- Therapeutica
- Dieet, voedsel en voeding
- Fysiologische fenomenen
- Nutritionele fysiologische fenomenen
- Dieettherapie
- Voedingstherapie
- Dieet
- Dieet, koolhydraat stapeling
Andere studie-ID-nummers
- ASO.ChirPed.24.05
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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