Preoperative FastingNCT07482345
Impact of Different Fasting Strategies on Gastric Ultrasound and Anxiety Levels in Children
A study testing Carbohydrate-loading fluid and Sip-till-send clear fluid in people with Preoperative Fasting and Enhanced Recovery After Surgery (ERAS) Protocol, run by Bursa City Hospital at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Preoperative Fasting, Enhanced Recovery After Surgery (ERAS) Protocol, Pediatric Surgery
- What is being tested?
- Carbohydrate-loading fluid and Sip-till-send clear fluid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 25 Mar 2026to 2 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients scheduled to undergo elective surgery under general anesthesia or sedoanalgesia 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
Who cannot join
- 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
Show all 10Show fewer
- Diabetes mellitus or endocrine/metabolic disorders that may affect perioperative glucose metabolism
- Cognitive or communication impairments that may interfere with compliance with the study protocol
- Grade 2 gastric fullness, defined as clear fluid visible in both the supine and right lateral decubitus positions, detected on preoperative gastric ultrasonography.
- Lack of written informed consent from parents or legal guardians for participation in the study
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
University of Health Sciences, Bursa City Hospital
Bursa, Bursa, 16110
University of Health Sciences, Bursa City Hospital
Bursa, Nilufer, 16110
About this study
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
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.
Read more
The children's anxiety levels will be evaluated before surgery using a validated anxiety scale and assess stomach content and volume using gastric ultrasound. including gastric ultrasound findings (antral cross-sectional area, estimated gastric residual volume, and gastric fullness grade), gastric pH, blood glucose levels, and time to discharge readiness assessed using Ped-PADSS, will be evaluated. Additional clinical outcomes, including postoperative nausea, vomiting, pain, and delirium, time to first oral intake, and lengths of stay in the post-anesthesia care unit and hospital, will also be evaluated.
The results may help determine safer and more comfortable fasting strategies for children undergoing surgery.
Read the 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). For the supplementary categorical analysis, high anxiety was defined as an m-YPAS score ≥40, based on the cutoff reported in the Turkish validation study by Hatipoğlu et al. (2019). This cutoff differs from the threshold reported in the original m-YPAS validation study.
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) including gastric ultrasound findings (antral cross-sectional area, estimated gastric residual volume, and gastric fullness grade), gastric pH, blood glucose levels, and time to discharge readiness assessed using Ped-PADSS, will be evaluated. Additional clinical outcomes, including postoperative nausea, vomiting, pain, and delirium, time to first oral intake, and lengths of stay in the post-anesthesia care unit and hospital, will also be evaluated.
- Being tested
- Carbohydrate-loading fluid, Sip-till-send clear fluid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate-loading fluidDietary supplement
Pulp-free clear apple juice (Cappy® Apple Juice, 200 mL pack, 12 g carbohydrate/100 mL, 49.5 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 fluidDietary supplement
Patients will consume small sips of water approximately every 60 minutes after midnight until they are called to the operating room (maximum total volume 10 mL/kg).
| Study group | Role | What they receive |
|---|---|---|
| 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 12 g carbohydrate per 100 mL (49.5 kcal/100 mL) at a dose of 5 mL/kg, administered 2 hours before surgery (maximum volume 200 mL). Receives: Dietary Supplement: Carbohydrate-loading fluid |
| 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 water approximately every 60 minutes after midnight until they are called to the operating room, with the total volume limited to 10 mL/kg. Receives: Dietary Supplement: Sip-till-send clear fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative anxiety assessed using the Modified Yale Preoperative Anxiety Scale (m-YPAS)
Preoperative anxiety is assessed using the Modified Yale Preoperative Anxiety Scale (m-YPAS) in the preoperative preparation area, before induction of anesthesia (T1). 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. The total scores range from 23.33 to 100, with higher scores indicating greater anxiety.
A total m-YPAS score ≥40 will be considered indicative of high anxiety (based on the Turkish validation study by Hatipoğlu et al. (2019). This cut-off differs from the threshold reported in the original m-YPAS validation study.)
Measured: Preoperatively, in the preoperative preparation area, before induction of anesthesia (T1).
Secondary outcomes (7)
Gastric antral fullness assessed by ultrasonography (Perlas grade)
Gastric antral fullness is assessed by ultrasonography in the supine and right lateral decubitus positions using the Perlas grading system (grades 0-2). Grade 0 indicates an empty antrum in both positions; grade 1 indicates clear fluid visible only in the right lateral decubitus position; and grade 2 indicates clear fluid visible in both positions. Solid or particulate gastric contents are recorded separately.
Measured: Preoperatively, in the preoperative preparation area, before induction of anesthesia.
Gastric antral cross-sectional area assessed by ultrasonography
Gastric antral cross-sectional area (CSA), expressed in cm², is measured in the supine and right lateral decubitus positions. CSA is obtained by freehand tracing of the outer antral border and by the ellipse method using two perpendicular diameters: CSA = π × D1 × D2 / 4.
Measured: Preoperatively, in the preoperative preparation area, before induction of anesthesia.
Estimated gastric residual volume (mL)
Gastric residual volume is estimated using the Spencer pediatric prediction model: volume (mL) = -7.8 + (3.5 × RLD-CSA) + (0.127 × age). RLD-CSA is the antral cross-sectional area measured by freehand tracing in the right lateral decubitus position, expressed in cm²; age is expressed in months. Negative predicted volumes are set to zero for analysis.
Measured: Preoperatively, in the preoperative preparation area, before induction of anesthesia.
Capillary blood glucose level (mg/dL)
Capillary blood glucose is measured from a fingertip blood sample using a portable glucometer. Results are reported in mg/dL. For this study, hypoglycemia is defined as a blood glucose level <65 mg/dL.
Measured: Intraoperatively, after induction of anesthesia and before the start of surgery.
Estimated gastric residual volume per kilogram of body weight (mL/kg)
Gastric residual volume estimated using the Spencer pediatric prediction model, based on right lateral decubitus antral cross-sectional area measured by freehand tracing and age in months, is divided by body weight in kilograms and reported as mL/kg. Negative predicted volumes are set to zero before weight normalization.
Measured: Preoperatively, in the preoperative preparation area, before induction of anesthesia.
Gastric pH
After induction of anesthesia, gastric contents are aspirated through an age-appropriate orogastric catheter. Gastric pH is measured semi-quantitatively using pH indicator paper with a measurement range of 0-14, by comparing the resulting color with the manufacturer's reference chart. Lower pH values indicate greater gastric acidity.
Measured: Intraoperatively, after induction of anesthesia.
Time to discharge readiness (Ped-PADSS ≥9)
Discharge readiness is assessed using the Pediatric Post-Anesthesia Discharge Scoring System (Ped-PADSS). Its five domains-hemodynamic stability, awakening, nausea and vomiting, pain, and surgical bleeding-are each scored from 0 to 2. Total scores range from 0 to 10, with higher scores indicating greater discharge readiness. The outcome is the time, in minutes, from admission to the post-anesthesia care unit (PACU) until the first Ped-PADSS score ≥9, rather than the time of actual hospital discharge.
Measured: From admission to the PACU until the first Ped-PADSS score ≥9, up to 24 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start25 Mar 2026
- Primary completion31 Jul 2026
- Study completion2 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Preoperative FastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hande Gurbuz, Bursa City Hospital
- Investigators
- Hande Gurbuz, Prof, MD, PhD, Principal investigator, University of Health Sciences, Bursa School of Medicine, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482345
- Sponsor's protocol ID
- 2025-KAEK-47 2026-1/6
- Status last verified
- Oct 2026
- First submitted
- 16 Mar 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets used in this research may be made available upon reasonable request to the corresponding author.
Publications
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.
PubMed 38615661Schmitz 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.
PubMed 21999211Frykholm 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.
PubMed 40410101Joshi 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.
PubMed 36629465Frykholm 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.
PubMed 34857683Dennhardt 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.
PubMed 26351828van 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.
PubMed 21422093Fearon 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.
PubMed 15896435
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07482345
- Acronym / sponsor ID
- 2025-KAEK-47 2026-1/6
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Bursa City HospitalOther government
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 2 Aug 2026 (actual)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. including gastric ultrasound findings (antral cross-sectional area, estimated gastric residual volume, and gastric fullness grade), gastric pH, blood glucose levels, and time to discharge readiness assessed using Ped-PADSS, will be evaluated. Additional clinical outcomes, including postoperative nausea, vomiting, pain, and delirium, time to first oral intake, and lengths of stay in the post-anesthesia care unit and hospital, will also 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). For the supplementary categorical analysis, high anxiety was defined as an m-YPAS score ≥40, based on the cutoff reported in the Turkish validation study by Hatipoğlu et al. (2019). This cutoff differs from the threshold reported in the original m-YPAS validation study.
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) including gastric ultrasound findings (antral cross-sectional area, estimated gastric residual volume, and gastric fullness grade), gastric pH, blood glucose levels, and time to discharge readiness assessed using Ped-PADSS, will be evaluated. Additional clinical outcomes, including postoperative nausea, vomiting, pain, and delirium, time to first oral intake, and lengths of stay in the post-anesthesia care unit and hospital, will also be evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Dietary Supplement: Carbohydrate-loading fluidIn the carbohydrate loading group, in addition to the institution's routine traditional preoperative fasting protocol, patients will receive an oral carbohydrate drink containing 12 g carbohydrate per 100 mL (49.5 kcal/100 mL) at a dose of 5 mL/kg, administered 2 hours before surgery (maximum volume 200 mL). |
| Sip-till-send | Experimental | Dietary Supplement: Sip-till-send clear fluidIn 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 water approximately every 60 minutes after midnight until they are called to the operating room, with the total volume limited to 10 mL/kg. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients scheduled to undergo elective surgery under general anesthesia or sedoanalgesia 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbohydrate-loading fluidPulp-free clear apple juice (Cappy® Apple Juice, 200 mL pack, 12 g carbohydrate/100 mL, 49.5 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 supplement | Carbohydrate loading |
| Sip-till-send clear fluidPatients will consume small sips of water approximately every 60 minutes after midnight until they are called to the operating room (maximum total volume 10 mL/kg). | Dietary supplement | Sip-till-send |
Primary outcome
Preoperative anxiety assessed using the Modified Yale Preoperative Anxiety Scale (m-YPAS)
Time frame: Preoperatively, in the preoperative preparation area, before induction of anesthesia (T1).
Preoperative anxiety is assessed using the Modified Yale Preoperative Anxiety Scale (m-YPAS) in the preoperative preparation area, before induction of anesthesia (T1). 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. The total scores range from 23.33 to 100, with higher scores indicating greater anxiety. A total m-YPAS score ≥40 will be considered indicative of high anxiety (based on the Turkish validation study by Hatipoğlu et al. (2019). This cut-off differs from the threshold reported in the original m-YPAS validation study.)
7 secondary outcomes
Gastric antral fullness assessed by ultrasonography (Perlas grade)
Time frame: Preoperatively, in the preoperative preparation area, before induction of anesthesia.
Gastric antral cross-sectional area assessed by ultrasonography
Time frame: Preoperatively, in the preoperative preparation area, before induction of anesthesia.
Estimated gastric residual volume (mL)
Time frame: Preoperatively, in the preoperative preparation area, before induction of anesthesia.
Capillary blood glucose level (mg/dL)
Time frame: Intraoperatively, after induction of anesthesia and before the start of surgery.
Estimated gastric residual volume per kilogram of body weight (mL/kg)
Time frame: Preoperatively, in the preoperative preparation area, before induction of anesthesia.
Gastric pH
Time frame: Intraoperatively, after induction of anesthesia.
Time to discharge readiness (Ped-PADSS ≥9)
Time frame: From admission to the PACU until the first Ped-PADSS score ≥9, up to 24 hours postoperatively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Results publication: PubMed 38615661Bozoglu 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.
- Results publication: PubMed 21999211Schmitz 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.
- Results publication: PubMed 40410101Frykholm 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.
- Results publication: PubMed 36629465Joshi 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.
- Results publication: PubMed 34857683Frykholm 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.
- Results publication: PubMed 26351828Dennhardt 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.
- Results publication: PubMed 21422093van 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.
- Results publication: PubMed 15896435Fearon 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.
- Individual participant dataSharing planned: Yes. The data sets used in this research may be made available upon reasonable request to the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hande Gurbuz, Prof, MD, PhD principal investigator
University of Health Sciences, Bursa School of Medicine, Bursa City Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate-loading fluid and Sip-till-send clear fluid in people with Preoperative Fasting and Enhanced Recovery After Surgery (ERAS) Protocol, run by Bursa City Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative anxiety assessed using the Modified Yale Preoperative Anxiety Scale (m-YPAS) (time frame: Preoperatively, in the preoperative preparation area, before induction of anesthesia (T1).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07482345, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.