NCT07482345

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Bursa City Hospital · Other Government
• Sex: All
• Age: 2 Years – 12 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Preoperative Fasting
• Enhanced Recovery After Surgery (ERAS) Protocol
• Pediatric Surgery

Interventions

Type	Name	Description
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)
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).

Timeline

• Start date: 2026-03-25
• Primary completion: 2027-03-30
• Completion: 2027-04-30
• First posted: 2026-03-19
• Last updated: 2026-03-23

Locations

1 site across 1 country: Turkey (Türkiye)