Impact of Different Fasting Strategies on Gastric Ultrasound and Anxiety Levels in Children

March 19, 2026 updated by: Hande Gurbuz, Bursa City Hospital

Impact of Three Different Preoperative Fasting Strategies on Gastric Ultrasound Findings and Anxiety Levels in Children Undergoing Inguinoscrotal Surgery: A Prospective Randomized Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Enhanced Recovery After Surgery (ERAS) protocols are evidence-based perioperative strategies designed to attenuate the surgical stress response, maintain metabolic stability, and accelerate postoperative recovery¹. Within ERAS pathways, shortening preoperative fasting duration and allowing the intake of oral carbohydrate-containing clear fluids play an important role.

In pediatric patients undergoing elective surgery under general anesthesia, prolonged preoperative fasting has been associated with dehydration, hypoglycemia, increased catabolism, and significant preoperative anxiety²-³, all of which may negatively influence perioperative outcomes. Consequently, pediatric preoperative fasting practices have been reassessed in recent years by several scientific societies⁴.

According to the most recent guideline published by the American Society of Anesthesiologists (ASA) in 2023, the recommended fasting period for clear fluids in children is 2 hours before anesthesia⁵. However, European guidelines suggest that the intake of clear fluids can be safely continued up to 1 hour before anesthesia in healthy pediatric patients⁴. Despite these updated recommendations, traditional fasting practices remain common in clinical settings, often resulting in unnecessarily prolonged fasting times in children.

Various approaches ranging from traditional overnight fasting to more liberal strategies-such as preoperative oral carbohydrate loading and the Sip-Til-Send protocol (allowing clear fluid intake until the patient is called to the operating room)⁴-⁶-have been proposed. Large prospective studies have demonstrated that shortened and liberal clear-fluid fasting protocols do not increase the risk of pulmonary aspiration in elective pediatric surgery⁶. Nevertheless, randomized and objective data comparing the effects of these protocols on gastric volume and perioperative comfort parameters-such as anxiety, nausea, vomiting, and pain-remain limited.

Gastric ultrasonography is a non-invasive, repeatable, and reliable bedside method for assessing gastric content and volume, providing an objective evaluation related to aspiration risk⁷.

In addition, validated assessment tools such as the Modified Yale Preoperative Anxiety Scale (m-YPAS) enable quantitative evaluation of perioperative psychological stress in children⁸-⁹.

Evaluating these objective and patient-centered outcomes within a randomized controlled design may contribute to determining optimal fasting strategies in pediatric anesthesia.

Therefore, the primary aim of this study is to compare the effects of different preoperative fasting protocols (standard fasting, preoperative carbohydrate loading, and the Sip-Til-Send approach) on preoperative anxiety levels in pediatric patients undergoing elective surgery, using the Modified Yale Preoperative Anxiety Scale (m-YPAS).

As secondary outcomes, the investigators aimed to evaluate the effects of these fasting strategies on gastric ultrasound findings (antral cross-sectional area [CSA], gastric volume, and fluid grading) as well as perioperative comfort and safety parameters, including nausea-vomiting, pain, emergence delirium, hemodynamic variables, and blood glucose levels.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Bursa
      • Bursa, Bursa, Turkey (Türkiye), 16110
        • University of Health Sciences, Bursa City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
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.
Experimental: Sip-till-send
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
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).
Experimental: Carbohydrate loading
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
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: postoperative 1st hour
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric Ultrasonography
Time Frame: Immediately before surgery
Gastric fullness will be assessed using gastric ultrasonography.
Immediately before surgery
Gastric pH
Time Frame: Intraoperative
After anesthesia induction and establishment of a secure airway, an age-appropriate single-use orogastric aspiration catheter will be inserted under aseptic conditions. Once correct gastric placement is clinically confirmed, gastric contents will be aspirated using a 5-20 mL syringe. The aspirate will be applied to pre-calibrated pH indicator paper suitable for clinical use, and gastric pH will be measured qualitatively/semi-quantitatively.
Intraoperative
Blood Glucose Level
Time Frame: Intraoperative
Capillary blood samples will be obtained from a fingertip under aseptic conditions after anesthesia induction and securing airway.
Intraoperative
Discharge Readiness
Time Frame: Postoperative 24 hours
Readiness for discharge will be assessed using the Pediatric Post-Anesthesia Discharge Scoring System (Ped-PADSS). This scoring system consists of five domains: hemodynamic stability, level of consciousness/awakening, nausea-vomiting, pain control, and surgical bleeding. Each parameter is scored from 0 to 2, with a maximum total score of 10. A Ped-PADSS score ≥9 will be considered adequate for discharge readiness. The time elapsed from admission to the post-anesthesia care unit (PACU) until reaching the discharge threshold (≥9/10) will be recorded as the time to discharge readiness.
Postoperative 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bursa City Hospital

Investigators

  • Principal Investigator: Hande Gurbuz, Prof, MD, PhD, University of Health Sciences, Bursa School of Medicine, Bursa City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 25, 2026

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

March 16, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2025-KAEK-47 2026-1/6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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