NCT07482345

Brief Summary

Children who undergo surgery are usually asked to stop eating and drinking for several hours before anesthesia to reduce the risk of stomach contents entering the lungs. However, long fasting times may cause discomfort, dehydration, low blood sugar, and increased anxiety in children. Recent guidelines suggest that clear liquids can safely be allowed closer to the time of surgery, and some enhanced recovery protocols even recommend giving carbohydrate-containing drinks before anesthesia. This study will compare three different preoperative fasting approaches in children undergoing elective inguinoscrotal surgery: traditional fasting, preoperative carbohydrate drinks, and the "Sip-Til-Send" approach, which allows clear fluids until the child is called to the operating room. The children's anxiety levels will be evaluated before surgery using a validated anxiety scale and assess stomach content and volume using gastric ultrasound. The secondary outcomes such as nausea, vomiting, pain, emergence delirium, and blood glucose levels will be evaluated. The results may help determine safer and more comfortable fasting strategies for children undergoing surgery.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Mar 2026Apr 2027

First Submitted

Initial submission to the registry

March 16, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

March 25, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

March 16, 2026

Last Update Submit

March 19, 2026

Conditions

Preoperative FastingEnhanced Recovery After Surgery (ERAS) ProtocolPediatric Surgery

Outcome Measures

Primary Outcomes (1)

  • Anxiety

    Anxiety will be assessed using the Modified Yale Preoperative Anxiety Scale (m-YPAS). The m-YPAS consists of five domains: (1) activity, (2) vocalizations, (3) emotional expressivity, (4) state of apparent arousal, and (5) use of a parent. Each domain is scored from 1 to 4, where 1 represents the lowest level and 4 the highest level of anxiety-related behavior. A total m-YPAS score \>30 will be considered indicative of high anxiety.

    postoperative 1st hour

Secondary Outcomes (4)

  • Gastric Ultrasonography

    Immediately before surgery

  • Gastric pH

    Intraoperative

  • Blood Glucose Level

    Intraoperative

  • Discharge Readiness

    Postoperative 24 hours

Study Arms (3)

Control

NO INTERVENTION

The standard traditional preoperative fasting protocol, "nil per os (NPO)," will be applied, with restriction of oral intake starting from midnight (24:00) prior to surgery.

Carbohydrate loading

EXPERIMENTAL

In the carbohydrate loading group, in addition to the institution's routine traditional preoperative fasting protocol, patients will receive an oral carbohydrate drink containing 10% sugar (48 kcal/100 mL) at a dose of 5 mL/kg, administered 2 hours before surgery (maximum volume 200 mL).

Dietary Supplement: Carbohydrate-loading fluid

Sip-till-send

EXPERIMENTAL

In the Sip-Til-Send group, in addition to the institution's routine traditional preoperative fasting protocol, patients will be allowed to consume small sips of clear fluids (apple juice and water) approximately every 60 minutes after midnight until they are called to the operating room, with the total volume limited to 10 mL/kg.

Dietary Supplement: Sip-till-send clear fluid

Interventions

Carbohydrate-loading fluidDIETARY_SUPPLEMENT

Pulp-free clear apple juice (Cappy® Apple Juice, 200 mL pack, 10% sugar, 48 kcal/100 mL; Coca-Cola, Türkiye) will be administered as an oral carbohydrate drink at a dose of 5 mL/kg, 2 hours before surgery (maximum volume: 200 mL)

Carbohydrate loading
Sip-till-send clear fluidDIETARY_SUPPLEMENT

Patients will consume small sips of clear fluids (pulp-free clear apple juice \[Cappy® Apple Juice, 200 mL pack, 10% sugar, 48 kcal/100 mL; Coca-Cola, Türkiye\] and water) approximately every 60 minutes after midnight until they are called to the operating room (maximum total volume 10 mL/kg).

Sip-till-send

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients scheduled to undergo elective surgery under general anesthesia for circumcision, undescended testis, inguinal hernia, and/or hypospadias (inguinoscrotal surgery)
  • Patients with an ASA physical status classification of I-II
  • Patients able to tolerate oral intake in the preoperative period and comply with the assigned fasting protocol
  • Written informed consent obtained from parents or legal guardians

You may not qualify if:

  • Patients with ASA physical status III or higher
  • Patients requiring emergency surgery
  • History of gastroesophageal reflux disease, gastrointestinal motility disorders, or metabolic/neurological diseases affecting gastric emptying
  • History of upper gastrointestinal surgery
  • Active upper respiratory tract infection or lower respiratory tract infection within the previous 2-4 weeks
  • Severe pulmonary disease, including uncontrolled or moderate-to-severe persistent asthma, bronchopulmonary dysplasia, cystic fibrosis, interstitial lung disease, or other chronic lung diseases
  • Diabetes mellitus or endocrine/metabolic disorders that may affect perioperative glucose metabolism
  • Obese patients with high aspiration risk (\>95th percentile for age)
  • Cognitive or communication impairments that may interfere with compliance with the study protocol
  • Grade 2 or Grade 3 gastric fullness detected on preoperative gastric ultrasonography
  • Lack of written informed consent from parents or legal guardians for participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences, Bursa City Hospital

Bursa, Bursa, 16110, Turkey (Türkiye)

Location

Related Publications (8)

  • Bozoglu Akgun B, Hatipoglu Z, Gulec E, Turktan M, Ozcengiz D. The Effect of Oral Fluid Administration 1 Hour before Surgery on Preoperative Anxiety and Gastric Volume in Pediatric Patients. Eur Surg Res. 2024;65(1):54-59. doi: 10.1159/000538842. Epub 2024 Apr 12.

    PMID: 38615661RESULT

  • Schmitz A, Thomas S, Melanie F, Rabia L, Klaghofer R, Weiss M, Kellenberger C. Ultrasonographic gastric antral area and gastric contents volume in children. Paediatr Anaesth. 2012 Feb;22(2):144-9. doi: 10.1111/j.1460-9592.2011.03718.x. Epub 2011 Oct 14.

    PMID: 21999211RESULT

  • Frykholm P, Modiri AR, Klaucane A, Beck CE, Bouvet L, Isserman RS, Oshan V, Stricker PA, Quintao VC, Frithiof R; EUROFAST Collaborative Group. Impact of liberal preoperative clear fluid fasting regimens on the risk of pulmonary aspiration in children (EUROFAST): an international prospective cohort study. Br J Anaesth. 2025 Jul;135(1):141-147. doi: 10.1016/j.bja.2025.03.031. Epub 2025 May 26.

    PMID: 40410101RESULT

  • Joshi GP, Abdelmalak BB, Weigel WA, Harbell MW, Kuo CI, Soriano SG, Stricker PA, Tipton T, Grant MD, Marbella AM, Agarkar M, Blanck JF, Domino KB. 2023 American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting: Carbohydrate-containing Clear Liquids with or without Protein, Chewing Gum, and Pediatric Fasting Duration-A Modular Update of the 2017 American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting. Anesthesiology. 2023 Feb 1;138(2):132-151. doi: 10.1097/ALN.0000000000004381.

    PMID: 36629465RESULT

  • Frykholm P, Disma N, Andersson H, Beck C, Bouvet L, Cercueil E, Elliott E, Hofmann J, Isserman R, Klaucane A, Kuhn F, de Queiroz Siqueira M, Rosen D, Rudolph D, Schmidt AR, Schmitz A, Stocki D, Sumpelmann R, Stricker PA, Thomas M, Veyckemans F, Afshari A. Pre-operative fasting in children: A guideline from the European Society of Anaesthesiology and Intensive Care. Eur J Anaesthesiol. 2022 Jan 1;39(1):4-25. doi: 10.1097/EJA.0000000000001599.

    PMID: 34857683RESULT

  • Dennhardt N, Beck C, Huber D, Nickel K, Sander B, Witt LH, Boethig D, Sumpelmann R. Impact of preoperative fasting times on blood glucose concentration, ketone bodies and acid-base balance in children younger than 36 months: A prospective observational study. Eur J Anaesthesiol. 2015 Dec;32(12):857-61. doi: 10.1097/EJA.0000000000000330.

    PMID: 26351828RESULT

  • van Veen MR, van Hasselt PM, de Sain-van der Velden MG, Verhoeven N, Hofstede FC, de Koning TJ, Visser G. Metabolic profiles in children during fasting. Pediatrics. 2011 Apr;127(4):e1021-7. doi: 10.1542/peds.2010-1706. Epub 2011 Mar 21.

    PMID: 21422093RESULT

  • Fearon KC, Ljungqvist O, Von Meyenfeldt M, Revhaug A, Dejong CH, Lassen K, Nygren J, Hausel J, Soop M, Andersen J, Kehlet H. Enhanced recovery after surgery: a consensus review of clinical care for patients undergoing colonic resection. Clin Nutr. 2005 Jun;24(3):466-77. doi: 10.1016/j.clnu.2005.02.002. Epub 2005 Apr 21.

    PMID: 15896435RESULT

Study Officials

  • Hande Gurbuz, Prof, MD, PhD

    University of Health Sciences, Bursa School of Medicine, Bursa City Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hande Gurbuz, Prof, MD, PhD

CONTACT

+905336515650handegrbz@gmail.com

Nazik Zehra Kibic, MD

CONTACT

+90 555 830 09 98zehrakibic@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof, MD, PhD

Study Record Dates

First Submitted

March 16, 2026

First Posted

March 19, 2026

Study Start

March 25, 2026

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

The data sets used in this research may be made available upon reasonable request to the corresponding author.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Individual participant data (IPD) and supporting information will be available upon reasonable request to the corresponding author from the time of publication for a period of one year.
Access Criteria
De-identified individual participant data (IPD), including the study dataset and supporting documents (study protocol and statistical analysis plan), will be available to qualified researchers upon reasonable request to the corresponding author. Requests must include a brief research proposal describing the intended use of the data. Data sharing will be subject to review and approval by the study investigators and in accordance with institutional and ethical regulations.

Locations

TU(1)