Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-28 @ 8:30 AM
Study NCT ID:
NCT05570292
Status:
COMPLETED
Last Update Posted:
2023-05-15
First Post:
2022-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Effects of Preoperative Oral Domperidone on Gastric Residual Volume After Clear Fluid Ingestion in Patients Scheduled for Elective Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004294', 'term': 'Domperidone'}, {'id': 'D005492', 'term': 'Folic Acid'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-11', 'studyFirstSubmitDate': '2022-10-02', 'studyFirstSubmitQcDate': '2022-10-05', 'lastUpdatePostDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assess the effect of oral Domperidone preoperatively on gastric residual volume by ultrasound for patients undergoing elective surgeries under general anesthesia', 'timeFrame': 'first 2 hours preoperative', 'description': 'patients will receive 400 ml of apple juice as a clear fluid, two hours preoperatively, and oral Domperidone tab or placebo tab'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Residual Volume']}, 'descriptionModule': {'briefSummary': 'General Anesthesia requires preoperative fasting according to specific instructions. Regarding Fasting Guidelines, The American Society of Anesthesiologists (ASA) recommends patients to fast from fatty food or meat eight hours prior to surgery, non-human milk or light meal for six hours prior, breast milk for four hours prior, and clear liquids including water, pulp-free juice, and tea without milk for two hours prior to the anesthetic. ASA fasting guidelines application represents the primary method to avoid aspiration as it ensures that stomach is empty before induction of anesthesia. These guidelines cannot be applied on all cases as in urgent or emergent situations or in morbidities associated with delayed gastric emptying, like Diabetes mellitus and some neurological disorders ('}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of both sexes\n* aged between 18-65 years\n* who are categorized by ASA physical status as I or II\n* undergoing elective surgeries under general anesthesia\n\nExclusion Criteria:\n\n* Patients with known or suspected delayed gastric emptying (e.g. Diabetes mellitus) -psychiatric disorders\n* hypersensitivity to the study medications\n* peoples undergoing surgeries that associated with high incidence of Post operative nausea and vomiting (PONV) (e.g. Cholecystectomy, gynecological, ophthalmological, otorhinolaryngological, and laparoscopic surgeries).'}, 'identificationModule': {'nctId': 'NCT05570292', 'briefTitle': 'Study of Effects of Preoperative Oral Domperidone on Gastric Residual Volume After Clear Fluid Ingestion in Patients Scheduled for Elective Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Study of Effects of Preoperative Oral Domperidone on Gastric Residual Volume After Clear Fluid Ingestion in Patients Scheduled for Elective Surgeries: Prospective , Randomized ,Double Blinded Controlled Study', 'orgStudyIdInfo': {'id': 'FMASU MS210/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Domperidone', 'interventionNames': ['Drug: Domperidone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Folic acid', 'interventionNames': ['Drug: Folic acid']}], 'interventions': [{'name': 'Domperidone', 'type': 'DRUG', 'description': 'ultrasound guieded assesment of gastric residual volume will be done 2 h after oral injestion of domperidone tablet', 'armGroupLabels': ['Domperidone']}, {'name': 'Folic acid', 'type': 'DRUG', 'description': 'ultrasound guieded assesment of gastric residual volume will be done 2 h after oral injestion of folic acid tablet', 'armGroupLabels': ['Folic acid']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Amin Mohammed Alansary Amin Ahmed Helwa', 'investigatorAffiliation': 'Ain Shams University'}}}}