Enhanced Recovery After Surgery (ERAS) Protocol, Pediatric Surgery, Preoperative Fasting
Conditions
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.
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.
Interventions
DIETARY_SUPPLEMENTCarbohydrate-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_SUPPLEMENTSip-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).
Sponsors
Bursa City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | postoperative 1st hour | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Glucose Level | Intraoperative | Capillary blood samples will be obtained from a fingertip under aseptic conditions after anesthesia induction and securing airway. |
| Discharge Readiness | Postoperative 24 hours | 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. |
| Gastric Ultrasonography | Immediately before surgery | Gastric fullness will be assessed using gastric ultrasonography. |
| Gastric pH | Intraoperative | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTHande Gurbuz, Prof, MD, PhD
CONTACTNazik Zehra Kibic, MD
PRINCIPAL_INVESTIGATORHande Gurbuz, Prof, MD, PhD
University of Health Sciences, Bursa School of Medicine, Bursa City Hospital
Outcome results
None listed