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Clinical Trials in Turkey / NCT07482345
Recruiting Not applicable

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

NCT07482345 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-03-25
Last updated
2026-08-19

Condition(s) studied

Preoperative FastingEnhanced Recovery After Surgery (ERAS) ProtocolPediatric Surgery

Investigational drug(s) / intervention(s)

Carbohydrate-loading fluidSip-till-send clear fluid

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)

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).

Study 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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
12 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
University of Health Sciences, Bursa City Hospital Bursa Bursa Active Not Recruiting
University of Health Sciences, Bursa City Hospital Bursa Nilufer Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07482345 on ClinicalTrials.gov ↗ ← All trials in Turkey