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Impact of Different Fasting Strategies on Gastric Ultrasound and Anxiety Levels in Children

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Notable Primary endpoint(s) modified Show 9 more changesShow less
    • Trial completed
    • Final enrollment: 120 participants (planned 90)
    • Primary completion date changed from estimate of Mar 30, 2027 to Jul 31, 2026
    • Study completion date changed from estimate of Apr 30, 2027 to Aug 2, 2026
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: 4 to 7
    • Study description expanded, about 84 words
    • Site details revised at 2 of 2 sites
    • Publications: details revised at 8 of 8 entries
  2. Notable Recruitment opened
    • Study sites: 1 to 2
    v3
  3. Minor Interventions: Carbohydrate-loading fluid (Dietary Supplement) to Carbohydrate-loading fluid (Dietary Supplement), Sip-till-send clear fluid (Dietary Supplement)
    • Study description expanded, about 1 word
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07482345
Lead Sponsor Bursa City Hospital
Conditions
(from sponsor)
Preoperative Fasting, Enhanced Recovery After Surgery (ERAS) Protocol, Pediatric Surgery
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov