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

ConditionsPreoperative FastingEnhanced Recovery After Surgery (ERAS) ProtocolPediatric Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-12
SponsorBursa City Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Carbohydrate-loading fluid

    Dietary 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)

  • Sip-till-send clear fluid

    Dietary 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).

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: Carbohydrate loadingExperimental treatment 1 intervention
Group C: Sip-till-sendExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
postoperative 1st hour

Secondary outcomes

1

Gastric Ultrasonography

Gastric fullness will be assessed using gastric ultrasonography.

Time frame
Immediately before surgery
2

Gastric pH

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.

Time frame
Intraoperative
3

Blood Glucose Level

Capillary blood samples will be obtained from a fingertip under aseptic conditions after anesthesia induction and securing airway.

Time frame
Intraoperative
4

Discharge Readiness

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.

Time frame
Postoperative 24 hours

Other outcomes

Sponsors and contacts

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Bursa City Hospital

Lead sponsor

Source ClinicalTrials.gov

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