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
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Clinical Trial Center
- 전화번호: 0131206893
- 이메일: clinicaltrialcenter@ospedale.al.it
연구 장소
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Piedmont
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Alessandria, Piedmont, 이탈리아, 15121
- 모병
- Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo
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연락하다:
- Pediatric Surgery Unit Clinical Trial Center
- 전화번호: 0131206893
- 이메일: clinicaltrialcenter@ospedale.al.it
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
다른 이름들:
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위약 비교기: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Preoperative anxiety measured by Modified Yale Preoperative Anxiety Scale (m-YPAS)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postoperative pain assessed by Visual Analogue Scale (VAS)
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- ASO.ChirPed.24.05
개별 참가자 데이터(IPD) 계획
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