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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Clinical Trial Center
- Telefonnummer: 0131206893
- E-post: clinicaltrialcenter@ospedale.al.it
Studieorter
-
-
Piedmont
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Alessandria, Piedmont, Italien, 15121
- Rekrytering
- Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo
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Kontakt:
- Pediatric Surgery Unit Clinical Trial Center
- Telefonnummer: 0131206893
- E-post: clinicaltrialcenter@ospedale.al.it
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
Andra namn:
|
|
Placebo-jämförare: 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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Preoperative anxiety measured by Modified Yale Preoperative Anxiety Scale (m-YPAS)
Tidsram: 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.
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20 to 30 minutes before surgery
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Postoperative pain assessed by Visual Analogue Scale (VAS)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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.
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Within 6 hours after surgery
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Mentala störningar
- Metaboliska sjukdomar
- Störningar i glukosmetabolism
- Hyperinsulinism
- Beteende
- Närings- och metabola sjukdomar
- Matningsbeteende
- Ångeststörningar
- Insulinresistens
- Fasta
- Terapeutik
- Diet, mat och näring
- Fysiologiska fenomen
- Näringsfysiologiska fenomen
- Dieterapi
- Näringsterapi
- Diet
- Diet, Kolhydratladdning
Andra studie-ID-nummer
- ASO.ChirPed.24.05
Plan för individuella deltagardata (IPD)
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