Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
180 participants
INTERVENTIONAL
2024-11-01
2025-07-31
Brief Summary
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Detailed Description
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In this study, participants will be randomly assigned to one of two groups. Group E (early group) will receive up to 10 ml/kg of clear fluids (e.g., water, clear juice) one hour after the end of anesthesia, while Group T (traditional group) will receive the same amount two hours after anesthesia. Patients will be evaluated for readiness to drink based on recovery of consciousness, protective airway reflexes, and absence of nausea or vomiting. Fluid will be administered slowly and under strict supervision by experienced staff, with emergency equipment readily available.
The incidence of vomiting will be assessed using a modified 4-point scale. Additional outcome measures include tolerability of oral fluids, time to readiness for discharge, and incidence of delayed postoperative vomiting on postoperative days 1 and 3, assessed via phone interviews with caregivers. This study seeks to provide evidence-based guidance on the optimal timing and volume of clear fluid intake in pediatric patients following ambulatory minor surgical procedures, contributing to more flexible and patient-centered perioperative fasting protocols.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Early Oral Intake Group (Group E)
Patients in this group will receive a maximum of 10 ml/kg of clear fluids (e.g., water or clear fruit juice) starting at 1 hour after the completion of general anesthesia.
Early Oral Fluid Intake
Participants receive clear fluids up to 10 ml/kg at 1 hour after anesthesia.
Traditional Oral Intake Group (Group T)
Patients in this group will receive a maximum of 10 ml/kg of clear fluids (e.g., water or clear fruit juice) starting at 2 hours after the completion of general anesthesia.
Traditional Oral Fluid Intake
Participants receive clear fluids up to 10 ml/kg at 2 hours after anesthesia.
Interventions
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Early Oral Fluid Intake
Participants receive clear fluids up to 10 ml/kg at 1 hour after anesthesia.
Traditional Oral Fluid Intake
Participants receive clear fluids up to 10 ml/kg at 2 hours after anesthesia.
Eligibility Criteria
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Inclusion Criteria
* ASA Physical Status I or II
* Undergoing elective, outpatient, non-gastrointestinal surgery under general anesthesia
* Expected to be discharged on the same day
* Parent/guardian provides informed consent
Exclusion Criteria
* History of gastrointestinal disorders
* History of aspiration or recurrent vomiting
* Children with neurodevelopmental delay
* Intraoperative complications requiring ICU admission
* Refusal of oral intake postoperatively
1 Year
8 Years
ALL
Yes
Sponsors
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Ankara City Hospital Bilkent
OTHER
Responsible Party
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Principal Investigators
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Feyza Sever, Assoc Prof
Role: PRINCIPAL_INVESTIGATOR
Ankara City Hospital Bilkent
Locations
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Ankara City Hospital Bilkent
Ankara, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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E2-24-6970
Identifier Type: -
Identifier Source: org_study_id
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