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Clinical Trial NCT07482345 for Preoperative Fasting, Enhanced Recovery After Surgery (ERAS) Protocol, Pediatric Surgery is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Impact of Different Fasting Strategies on Gastric Ultrasound and Anxiety Levels in Children 90

Not yet recruiting
Clinical Trial NCT07482345 is an interventional study for Preoperative Fasting, Enhanced Recovery After Surgery (ERAS) Protocol, Pediatric Surgery and is currently not yet recruiting. Enrollment is planned to begin on 25 March 2026 and continue until the study accrues 90 participants. Led by Bursa City Hospital, this study is expected to complete by 30 April 2027. The latest data from ClinicalTrials.gov was last updated on 23 March 2026.
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 ...Show More
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 surger...

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Official Title

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

Conditions
Preoperative FastingEnhanced Recovery After Surgery (ERAS) ProtocolPediatric Surgery
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • 2025-KAEK-47 2026-1/6
NCT ID Number
NCT07482345
Start Date (Actual)
2026-03-25
Last Update Posted
2026-03-23
Completion Date (Estimated)
2027-04-30
Enrollment (Estimated)
90
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Primary Purpose
Screening
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
No InterventionControl
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.
N/A
ExperimentalCarbohydrate 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).
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)
ExperimentalSip-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.
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).
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
postoperative 1st hour
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Gastric Ultrasonography
Gastric fullness will be assessed using gastric ultrasonography.
Immediately before surgery
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.
Intraoperative
Blood Glucose Level
Capillary blood samples will be obtained from a fingertip under aseptic conditions after anesthesia induction and securing airway.
Intraoperative
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.
Postoperative 24 hours
Participation Assistant
Eligibility Criteria

Eligible Ages
Child
Minimum Age
2 Years
Eligible Sexes
All
  • 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

  • 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
Bursa City Hospital logoBursa City Hospital
Study Responsible Party
Hande Gurbuz, Principal Investigator, Prof, MD, PhD, Bursa City Hospital
Study Central Contact
Contact: Hande Gurbuz, Prof, MD, PhD, +905336515650, [email protected]
Contact: Nazik Zehra Kibic, MD, +90 555 830 09 98, [email protected]
1 Study Locations in 1 Countries

Bursa

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