Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT05244902
Status:
COMPLETED
Last Update Posted:
2022-11-25
First Post:
2022-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gastric Emptying Times of Normal and Obese Children After Preoperative Clear Fluid Drinking: An Ultrasound Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005947', 'term': 'Glucose'}], 'ancestors': [{'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pediatric patients will be divided into two groups as obese and non-obese. Children above the 95% percentile will be considered as obese.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-23', 'studyFirstSubmitDate': '2022-02-08', 'studyFirstSubmitQcDate': '2022-02-08', 'lastUpdatePostDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Gastric emptying half-time ( t 1/2)', 'timeFrame': '90 minute', 'description': 'Time required for ACSA to return to half maximum value.'}, {'measure': 'Gastric volume', 'timeFrame': '90 minute', 'description': 'The mathematical model will be used which was reported by Perlas and colleagues based on gastroscopic fluid assessment will be used for the calculation of gastric volume (mL) from ACSA. GastricVolume(mL) = 27.0 + 14.6 x ACSA(cm2) -1.28 x Age(years)'}], 'primaryOutcomes': [{'measure': 'Gastric emptying time', 'timeFrame': '90 minute', 'description': 'Time until the gastric volume reaches the baseline level again.'}], 'secondaryOutcomes': [{'measure': 'Antral cross-sectional area', 'timeFrame': '90 minute', 'description': 'Antral cross-Section Area (ACSA) (cm2) maximal anteroposterior diameter (D1) and longitudinal diameter (D2) will be measured with ultrasound and calculated with that mathematical formula:\n\nACSA(cm2) = Π x D1 x D2 / 4'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastric volume', 'Gastric emptying time', 'Antral cross-sectional area (ACSA)', 'Obese pediatric patients'], 'conditions': ['Gastric Emptying Time']}, 'descriptionModule': {'briefSummary': 'In the recent literature, pre-operative fasting times for pediatric patients are limited to one hour for clear fluids. Studies related to gastric emptying times mostly searched for normal-weight children. These studies have claimed that 3 mL/kg clear fluid can be allowed up to 1 hour before surgery. There is a lack of interest in the gastric emptying time of obese pediatric patients during the preoperative period. In addition, there is controversy about gastric emptying times of obese healthy children. Some research committed the decrease of gastric emptying because of a high level of sensitivity to cholecystokinin, while others postulated that no change in gastric emptying time of obese children compared to normal weight. The aim of this trial is to compare the gastric volume and gastric emptying time after ingestion of 3 mL/kg clear fluid in obese and non-obese pediatric patients in the pre-operative period.', 'detailedDescription': 'After receiving informed consent from the children and their families, American Society of Anesthesiologists (ASA) 1-2 pediatric patients between 6-14 years, who will recruit for elective surgery will be included for this study. The children over 95% percentile will be accepted as obese. After, the basal gastric volume will be calculated with the help of Ultrasonography (USG). The children will receive oral 3 mL/kg(max 250 mL) 5% dextrose .USG evaluation will be made every 5 minutes until the gastric volume reaches the basal level. Children reaching basal gastric volume will be accepted as suitable for the surgery. The aim of this study is to compare the gastric volume and gastric emptying time after ingestion of 3 mL/kg clear fluid in obese and non-obese pediatric patients in the pre-operative period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA physical state I or II\n* Age 6 to 14 years.\n* Gender: both sexes.\n* Scheduled for non-Gastrointestinal Tract elective day-case surgery under general anesthesia.\n\nExclusion Criteria:\n\n* Parent/ care giver refusal\n* Ages \\< 6 or \\> 14 years old\n* Children with gastro-esophageal reflux disease\n* Renal failure\n* Diabetes mellitus\n* Cerebral palsy patients\n* Mental retardation\n* Esophageal strictures, achalasia or any intestinal disease that may impair the gastric emptying.\n* Gastrointestinal system surgery and neurosurgical patients\n* Emergency surgery\n* Violation of the prescribed fasting times\n* Refusing to drink prescribed clear fluid'}, 'identificationModule': {'nctId': 'NCT05244902', 'briefTitle': 'Gastric Emptying Times of Normal and Obese Children After Preoperative Clear Fluid Drinking: An Ultrasound Study', 'organization': {'class': 'OTHER', 'fullName': 'Karaman Training and Research Hospital'}, 'officialTitle': 'Gastric Emptying Times of Normal and Obese Children After Preoperative Clear Fluid Drinking: An Ultrasound Study', 'orgStudyIdInfo': {'id': '08-2021/12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Obese pediatric patient', 'description': 'Obese children aged 6-14 years, over 95% percentile, fasted for the night before planned surgery.', 'interventionNames': ['Drug: 5% Dextrose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-obese pediatric patient', 'description': 'Non-obese children aged 6-14 years, between 5-85% percentile, fasted for the night before planned surgery.', 'interventionNames': ['Drug: 5% Dextrose']}], 'interventions': [{'name': '5% Dextrose', 'type': 'DRUG', 'description': 'All the patients will receive oral 3mL/kg 5%Dextrose', 'armGroupLabels': ['Non-obese pediatric patient', 'Obese pediatric patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70200', 'city': 'Karaman', 'country': 'Turkey (Türkiye)', 'facility': 'Karaman Taining and Research Hospital', 'geoPoint': {'lat': 37.18111, 'lon': 33.215}}], 'overallOfficials': [{'name': 'Muhammet Korkusuz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karaman Training and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karaman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator, MD', 'investigatorFullName': 'muhammet korkusuz', 'investigatorAffiliation': 'Karaman Training and Research Hospital'}}}}