NCT07482345 Impact of Different Fasting Strategies on Gastric Ultrasound and Anxiety Levels in Children
| NCT ID | NCT07482345 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bursa City Hospital |
| Condition | Preoperative Fasting |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2026-03-25 |
| Primary Completion | 2027-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2026-03-25 with a primary completion date of 2027-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Hande Gurbuz, Prof, MD, PhD
PRINCIPAL INVESTIGATOR
University of Health Sciences, Bursa School of Medicine, Bursa City Hospital
Frequently Asked Questions
Who can join the NCT07482345 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 12 Years, studying Preoperative Fasting. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07482345 currently recruiting?
Yes, NCT07482345 is actively recruiting participants. Contact the research team at handegrbz@gmail.com for enrollment information.
Where is the NCT07482345 trial being conducted?
This trial is being conducted at Bursa, Turkey (Türkiye), Bursa, Turkey (Türkiye).
Who is sponsoring the NCT07482345 clinical trial?
NCT07482345 is sponsored by Bursa City Hospital. The principal investigator is Hande Gurbuz, Prof, MD, PhD at University of Health Sciences, Bursa School of Medicine, Bursa City Hospital. The trial plans to enroll 90 participants.