Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | 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. | |
| Carbohydrate loading | Experimental | 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). |
|
| Sip-till-send | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbohydrate-loading fluid | Dietary Supplement | 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) |
| Measure | Description | Time 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 |
| Measure | Description | Time 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hande Gurbuz, Prof, MD, PhD | Contact | +905336515650 | handegrbz@gmail.com | |
| Nazik Zehra Kibic, MD | Contact | +90 555 830 09 98 | zehrakibic@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hande Gurbuz, Prof, MD, PhD | University of Health Sciences, Bursa School of Medicine, Bursa City Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Health Sciences, Bursa City Hospital | Bursa | Bursa | 16110 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38615661 | Result | Bozoglu Akgun B, Hatipoglu Z, Gulec E, Turktan M, Ozcengiz D. The Effect of Oral Fluid Administration 1 Hour before Surgery on Preoperative Anxiety and Gastric Volume in Pediatric Patients. Eur Surg Res. 2024;65(1):54-59. doi: 10.1159/000538842. Epub 2024 Apr 12. | |
| 21999211 | Result | Schmitz A, Thomas S, Melanie F, Rabia L, Klaghofer R, Weiss M, Kellenberger C. Ultrasonographic gastric antral area and gastric contents volume in children. Paediatr Anaesth. 2012 Feb;22(2):144-9. doi: 10.1111/j.1460-9592.2011.03718.x. Epub 2011 Oct 14. |
Not provided
Not provided
The data sets used in this research may be made available upon reasonable request to the corresponding author.
Individual participant data (IPD) and supporting information will be available upon reasonable request to the corresponding author from the time of publication for a period of one year.
De-identified individual participant data (IPD), including the study dataset and supporting documents (study protocol and statistical analysis plan), will be available to qualified researchers upon reasonable request to the corresponding author. Requests must include a brief research proposal describing the intended use of the data. Data sharing will be subject to review and approval by the study investigators and in accordance with institutional and ethical regulations.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sip-till-send clear fluid | Dietary Supplement | 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). |
|
| 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 |
| 40410101 | Result | Frykholm P, Modiri AR, Klaucane A, Beck CE, Bouvet L, Isserman RS, Oshan V, Stricker PA, Quintao VC, Frithiof R; EUROFAST Collaborative Group. Impact of liberal preoperative clear fluid fasting regimens on the risk of pulmonary aspiration in children (EUROFAST): an international prospective cohort study. Br J Anaesth. 2025 Jul;135(1):141-147. doi: 10.1016/j.bja.2025.03.031. Epub 2025 May 26. |
| 36629465 | Result | Joshi GP, Abdelmalak BB, Weigel WA, Harbell MW, Kuo CI, Soriano SG, Stricker PA, Tipton T, Grant MD, Marbella AM, Agarkar M, Blanck JF, Domino KB. 2023 American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting: Carbohydrate-containing Clear Liquids with or without Protein, Chewing Gum, and Pediatric Fasting Duration-A Modular Update of the 2017 American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting. Anesthesiology. 2023 Feb 1;138(2):132-151. doi: 10.1097/ALN.0000000000004381. |
| 34857683 | Result | Frykholm P, Disma N, Andersson H, Beck C, Bouvet L, Cercueil E, Elliott E, Hofmann J, Isserman R, Klaucane A, Kuhn F, de Queiroz Siqueira M, Rosen D, Rudolph D, Schmidt AR, Schmitz A, Stocki D, Sumpelmann R, Stricker PA, Thomas M, Veyckemans F, Afshari A. Pre-operative fasting in children: A guideline from the European Society of Anaesthesiology and Intensive Care. Eur J Anaesthesiol. 2022 Jan 1;39(1):4-25. doi: 10.1097/EJA.0000000000001599. |
| 26351828 | Result | Dennhardt N, Beck C, Huber D, Nickel K, Sander B, Witt LH, Boethig D, Sumpelmann R. Impact of preoperative fasting times on blood glucose concentration, ketone bodies and acid-base balance in children younger than 36 months: A prospective observational study. Eur J Anaesthesiol. 2015 Dec;32(12):857-61. doi: 10.1097/EJA.0000000000000330. |
| 21422093 | Result | van Veen MR, van Hasselt PM, de Sain-van der Velden MG, Verhoeven N, Hofstede FC, de Koning TJ, Visser G. Metabolic profiles in children during fasting. Pediatrics. 2011 Apr;127(4):e1021-7. doi: 10.1542/peds.2010-1706. Epub 2011 Mar 21. |
| 15896435 | Result | Fearon KC, Ljungqvist O, Von Meyenfeldt M, Revhaug A, Dejong CH, Lassen K, Nygren J, Hausel J, Soop M, Andersen J, Kehlet H. Enhanced recovery after surgery: a consensus review of clinical care for patients undergoing colonic resection. Clin Nutr. 2005 Jun;24(3):466-77. doi: 10.1016/j.clnu.2005.02.002. Epub 2005 Apr 21. |